Tubes, Gastrointestinal (And Accessories)

FDA product code KNT · 625 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5980
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-23 – 2026-08-14

KNT 2026-08-14

52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®

Applicant Boehringer Laboratories, LLC

K number K261890

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KNT 2026-07-10

Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)

Applicant C.R. Bard, Inc.

K number K253514

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KNT 2025-04-10

XNY Disposable Gastric Calibration Tube

Applicant Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

K number K250389

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KNT 2025-03-28

Flexi-Seal AIR (with ENFit Connector)

Applicant Convatec

K number K243228

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KNT 2025-01-17

hygh-tec Drainage II

Applicant Amb Medtec

K number K242336

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KNT 2025-01-10

ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

Applicant Tools For Surgery, LLC

K number K242901

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KNT 2024-11-22

Entarik NI Feeding Tube System

Applicant Gravitas Medical, Inc.

K number K241169

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KNT 2024-10-25

CORGRIP* SR NG/NI Tube Retention System

Applicant Avanos Medical, Inc.

K number K241185

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KNT 2024-06-06

CORTRAK* 2 Enteral Access System (20-0950)

Applicant Avanos Medical, Inc.

K number K240965

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KNT 2024-05-31

Stylus

Applicant Degania Silicone , Ltd.

K number K233591

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KNT 2024-05-16

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

Applicant Reshape Lifesciences

K number K241039

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KNT 2024-05-06

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

Applicant Boehringer Laboratories, LLC

K number K234033

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KNT 2024-04-17

Enteral Feeding Sets

Applicant Hangzhou Primecare Medical Co., Ltd.

K number K240039

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KNT 2024-02-08

Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)

Applicant Endolumik

K number K240069

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KNT 2024-01-26

ViSiGi 3D Gastric Sizing Tube

Applicant Boehringer Laboratories

K number K234145

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KNT 2023-12-18

AMT G-Tube Balloon Gastrostomy Feeding Device

Applicant Applied Medical Technology, Inc.

K number K222846

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KNT 2023-03-24

Entarik Feeding Tube System; Entarik Feeding Tube

Applicant Gravitas Medical, Inc.

K number K230206

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KNT 2023-03-03

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

Applicant Endolumik, Inc.

K number K222880

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KNT 2023-02-15

ReShape Calibration Tubes

Applicant Reshape Lifesciences

K number K230131

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KNT 2023-02-09

hygh-tec drainage

Applicant Creative Balloons GmbH

K number K221400

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KNT 2022-10-31

Standard Tapered Bougie, 38 Fr.

Applicant Standard Bariatrics, Inc.

K number K222085

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KNT 2022-09-30

DoubleChek DC-1001

Applicant Nasogastric Feeding Solutions, Ltd.

K number K212316

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KNT 2022-07-28

Gastrointestinal Boundary Identifier (GIBI HD)

Applicant Reshape Lifesciences

K number K221898

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KNT 2022-07-26

Gastric Lightguide (GLG)

Applicant Naser Dib Gabinet Lekarksi Nasmed

K number K212407

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KNT 2022-06-07

Lap-Band System Calibration Tube

Applicant Reshape Lifesciences

K number K220455

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KNT 2022-05-18

Siren SGT

Applicant Tools For Surgery, LLC

K number K220218

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KNT 2022-04-22

Avanos* CORTRAK* 2 Enteral Access System (EAS)

Applicant Avanos Medical, Inc.

K number K220588

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KNT 2021-11-17

Qora Stool Management Kit

Applicant Cm Technologies, Inc.

K number K212444

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KNT 2021-09-23

Standard Bougie, 38 Fr. and Hand Pump

Applicant Standard Bariatrics

K number K212728

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KNT 2021-06-29

Standard Bougie, 38 Fr.

Applicant Standard Bariatrics

K number K210437

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KNT 2021-04-27

Safety Trocar Cannula

Applicant Boston Scientific Corporation

K number K211072

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KNT 2021-04-09

Enteral Feeding Catheter

Applicant Medcaptain Life Science Co., Ltd.

K number K202748

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KNT 2021-03-24

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube

Applicant Envizion Medical , Ltd.

K number K203133

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KNT 2020-12-04

TubeClear System

Applicant Actuated Medical, Inc.

K number K200646

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KNT 2020-10-29

Nutriglide(TM) Nasal Feeding Tube

Applicant Applied Medical Technology, Inc.

K number K202539

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KNT 2020-06-17

Entuit Nasal Jejunal Feeding Tube

Applicant Wilson-Cook Medical, Inc.

K number K201322

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KNT 2020-04-08

Standard Bougie

Applicant Standard Bariatrics

K number K191885

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KNT 2020-03-13

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Applicant Prosys International, Ltd.

K number K193325

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KNT 2019-11-22

Navina Smart System, Navina Classic System

Applicant Dentsply Sirona

K number K190977

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KNT 2019-10-11

McLean-Ring Enteral Feeding Tube Set

Applicant Cook Incorporated

K number K190084

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KNT 2019-06-14

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

Applicant Envizion Medical , Ltd.

K number K191387

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KNT 2019-06-04

CORTRAK* 2 Equilateral Enteral Access System

Applicant Avanos Medical, Inc.

K number K191340

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KNT 2019-05-29

Entuit PEG, Entuit PEGJ

Applicant Wilson-Cook Medical, Inc.

K number K183336

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KNT 2019-05-04

Medline Quick-Clear Wand

Applicant Medline Industries, Inc.

K number K183577

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KNT 2019-04-30

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

Applicant Convatec Limited

K number K190114

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KNT 2019-03-29

Micro Transgastric-Jejunal Feeding Device

Applicant Applied Medical Technology, Inc.

K number K183508

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KNT 2019-03-01

Traditional Length GJ Feeding Device

Applicant Applied Medical Technology, Inc.

K number K182804

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KNT 2019-02-13

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

Applicant Envizion Medical , Ltd.

K number K182915

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KNT 2018-11-13

Aspire Venting Tube

Applicant Aspire Bariatrics, Inc.

K number K182248

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KNT 2018-10-24

GastroFlush

Applicant Bionix Development Corporation

K number K180605

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KNT 2018-10-23

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port

Applicant Covidien

K number K180622

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KNT 2018-07-11

Aspire Introducer Needle

Applicant Aspire Bariatrics, Inc.

K number K180725

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KNT 2018-06-29

TubeClear System

Applicant Actuated Medical, Inc.

K number K172556

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KNT 2018-06-01

Bowel Management Device, Bowel Management Irrigation Set

Applicant Applied Medical Technology, Inc.

K number K180026

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KNT 2018-01-26

Mic-Key* SF Over-the-Wire Stoma Measuring Device

Applicant Halyard Health, Inc.

K number K173955

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KNT 2017-11-17

Gastric Sizing Balloon Catheter

Applicant Cook Incorporated

K number K173355

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KNT 2017-10-11

Stomach Tube

Applicant Well Lead Medical Co., Ltd.

K number K162340

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KNT 2017-10-06

Low Profile Non-Balloon Feeding Device

Applicant Applied Medical Technology, Inc.

K number K170319

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KNT 2017-09-11

Navina Classic System

Applicant Dentsply Sirona

K number K170487

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KNT 2017-05-18

Barone Jejunostomy Catheter Set

Applicant Cook Incorporated

K number K160567

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KNT 2017-05-18

Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube

Applicant Cook Incorporated

K number K160509

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KNT 2017-05-16

Kangaroo Feeding Tube with IRIS Technology

Applicant Covidien (Dba Medtronic)

K number K163002

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KNT 2017-03-07

Flexi-Seal PROTECT Fecal Management System

Applicant Convatec

K number K162906

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KNT 2017-02-09

Low Profile Balloon Feeding Device

Applicant Applied Medical Technology, Inc.

K number K161413

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KNT 2016-11-30

TubeClear Control Box and Clearing Stem

Applicant Actuated Medical, Inc.

K number K163092

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KNT 2016-09-15

CORGRIP NG/NI Tube Retention System

Applicant Corpak Medsystems, Inc. A Division of Haylard Health

K number K162110

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KNT 2016-08-09

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

Applicant Syncro Medical Innovations, Inc.

K number K160787

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KNT 2016-06-21

Aquarius Stoma Measuring Device

Applicant Degania Silicone , Ltd.

K number K152246

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KNT 2016-05-06

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

Applicant Consure Medical Pvt , Ltd.

K number K153506

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KNT 2016-05-04

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)

Applicant Covidien, LLC

K number K160654

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KNT 2013-12-19

ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE

Applicant Xeridiem Medical Devices

K number K130611

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KNT 2013-08-16

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)

Applicant Actuated Medical, Inc.

K number K131052

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KNT 2013-08-12

ELECTROMAGNETIC TRANSMITTING STYLET

Applicant Corpak Medsystems

K number K131532

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KNT 2013-06-26

MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES

Applicant Kimberly-Clark Corporation

K number K122653

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KNT 2013-04-19

AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT

Applicant Applied Medical Technology, Inc.

K number K123716

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KNT 2013-04-17

INSTAFLO BOWEL CATHETER SYSTEM KIT

Applicant Hollister, Inc.

K number K123804

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KNT 2013-03-28

BOEHRINGER GASTRIC SIZING TUBE

Applicant Boehringer Laboratories, LLC

K number K130483

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KNT 2012-12-20

TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)

Applicant Actuated Medical, Inc.

K number K123659

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KNT 2012-09-05

LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON

Applicant Degania Silicone , Ltd.

K number K122030

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KNT 2012-06-13

TUBECLEAR

Applicant Actuated Medical, Inc.

K number K121571

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KNT 2012-06-08

PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER

Applicant Coloplast A/S

K number K112860

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KNT 2012-05-11

DOBBHOFF DUAL PORT FEEDING TUBE

Applicant Covidien Lp, Formerly Registered AS Kendall

K number K112511

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KNT 2012-04-26

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM

Applicant Convatec, Inc.

K number K112342

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KNT 2012-04-20

SAFETY SCREW CONNECTOR

Applicant Abbott Laboratories

K number K113719

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KNT 2012-04-19

NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES

Applicant Neomed, Inc.

K number K120182

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KNT 2012-03-29

ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN

Applicant Acta Medical, LLC

K number K112863

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KNT 2012-03-19

CODAN SAFEFEED ENTERAL FEEDING RESERVOIR

Applicant Codan US Corp.

K number K112268

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KNT 2012-02-17

AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET

Applicant Kentec Medical, Inc.

K number K120272

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KNT 2012-01-10

CORTRAK ENTERAL ACCESS DEVICE

Applicant Corpak Medsystems

K number K113351

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KNT 2011-12-16

MED GRAVITY SET, IMED PUMP SET

Applicant Imed Technology, Inc.

K number K102712

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KNT 2011-11-08

ENTERAL FEEDING BAG AND SETS

Applicant Shandong Weigao Group Medical Polymer Co., Ltd.

K number K102741

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KNT 2011-10-19

AMT G-J TUBE

Applicant Applied Medical Technology, Inc.

K number K110804

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KNT 2011-09-29

BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION

Applicant Bd Medical Surgical

K number K112434

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KNT 2011-08-04

SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE

Applicant Syncro Medical Innovations, Inc.

K number K110005

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KNT 2011-07-22

ENDOFLIP GASTRIC TUBE

Applicant Crospon, Ltd.

K number K110529

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KNT 2011-01-31

PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE

Applicant Coloplast A/S

K number K103254

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KNT 2010-12-27

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

Applicant Sainath Intellectual Properties, LLC

K number K102572

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KNT 2010-12-22

PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE

Applicant C.R. Bard, Inc.

K number K103109

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KNT 2010-12-22

BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

Applicant C.R. Bard, Inc.

K number K102391

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KNT 2010-11-26

FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE

Applicant Footprint Medical, Inc.

K number K102548

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