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 2010-08-27

GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,

Applicant Maquet Critical Care AB

K number K101199

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KNT 2010-08-03

NEOMED ENTERAL ONLY EXTENSION SET

Applicant Neomed, Inc.

K number K100288

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KNT 2010-06-14

MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY

Applicant Maxter Catheters

K number K100366

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KNT 2010-05-20

FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV

Applicant Corpak Medsystems

K number K100365

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KNT 2010-05-20

ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET

Applicant Alan Reid

K number K092628

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KNT 2010-04-22

INSTAFLO BOWEL CATHETER SYSTEM KIT

Applicant Hollister, Inc.

K number K100273

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KNT 2010-04-16

IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT

Applicant Sainath Intellectual Properties, LLC

K number K100173

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KNT 2010-02-23

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK

Applicant Uresil, LLC

K number K093653

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KNT 2009-11-23

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

Applicant Coloplast A/S

K number K083770

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KNT 2009-10-23

ENTRACARE GASTROSTOMY FEEDING TUBE

Applicant Entracare, LLC

K number K092418

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KNT 2009-10-09

IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT

Applicant Sainath Intellectual Properties, LLC

K number K092049

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KNT 2009-09-29

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

Applicant Corpak Medsystems

K number K091637

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KNT 2009-09-18

SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H

Applicant Olympus Medical Systems Corporation

K number K091759

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KNT 2009-06-25

ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285

Applicant Mri Manufacturing and Research, Inc.

K number K083685

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KNT 2009-05-04

FOOTPRINT MEDICAL SILICONE FEEDING TUBE

Applicant Footprint Medical

K number K090559

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KNT 2009-02-05

ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX

Applicant Manufacturing & Research, Inc.

K number K083684

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KNT 2009-02-04

ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007

Applicant Hollister, Inc.

K number K083153

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KNT 2009-01-23

SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET

Applicant Neochild, LLC

K number K082710

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KNT 2009-01-09

DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)

Applicant Dynarex Corporation

K number K082863

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KNT 2008-12-03

2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT

Applicant Boston Scientific Corp

K number K081739

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KNT 2008-11-25

ENTERAL ONLY EXTENSION SET

Applicant Respironics, Inc.

K number K082654

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KNT 2008-11-07

ENTERAL PUMP SET, MODEL 20-1010

Applicant Viasys Medsystems

K number K081725

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KNT 2008-10-30

THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751

Applicant Dale Medical Products, Inc.

K number K082241

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KNT 2008-06-27

MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

Applicant Viasys Medsystems

K number K080679

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KNT 2008-06-13

BARD DIGNICARE STOOL MANAGEMENT SYSTEM

Applicant C.R. Bard, Inc.

K number K073598

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KNT 2008-05-14

MPS ACACIA ENTERAL FEEDING TUBE

Applicant Mps Acacia

K number K080328

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KNT 2008-03-14

AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)

Applicant Applied Medical Technology, Inc.

K number K073034

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KNT 2008-03-05

COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG

Applicant Novartis Nutrition Corp.

K number K080340

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KNT 2008-01-18

ENTERAL FEEDING SPIKE ADAPTER

Applicant Cedic S.R.L.

K number K072652

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KNT 2007-12-19

NON-IV ADAPTER FOR INFANT NG TUBE

Applicant Promedic, Inc.

K number K072756

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KNT 2007-12-14

THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT

Applicant Boston Scientific Corporation

K number K072476

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KNT 2007-12-07

SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301

Applicant Medevice, Inc.

K number K072550

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KNT 2007-11-20

PEF TUBE

Applicant N.M. Beale Co., Inc.

K number K071579

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KNT 2007-10-31

GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111

Applicant Syncro Medical Innovations, Inc.

K number K072787

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KNT 2007-10-24

REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360

Applicant Obtech Medical Sarl

K number K071764

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KNT 2007-06-14

LUMILOC (TM) SAFETY INTRODUCER NEEDLE

Applicant Specialized Health Products International, Inc.

K number K070449

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KNT 2007-05-23

GASTROSTOMY REPLACEMENT TUBE, MODEL 253

Applicant Degania Silicone , Ltd.

K number K070124

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KNT 2007-04-02

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

Applicant Viasys Medsystems

K number K063061

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KNT 2007-02-13

BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE

Applicant C.R. Bard, Inc.

K number K063118

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KNT 2006-09-11

HOSPIRA ENTERAL FEEDING SET, MODEL 20640

Applicant Hospira, Inc.

K number K061432

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KNT 2006-04-28

ENTAKE STANDARD AND SAFETY PEG SYSTEM

Applicant Conmedcorp

K number K061021

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KNT 2005-11-09

PEDIATRIC FEEDING TUBE

Applicant Promedic, Inc.

K number K052903

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KNT 2005-11-02

Y2K2 ENTERNAL TUBE FLUID FILTER

Applicant Moss Medical Products

K number K051206

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KNT 2005-06-28

SMALL INTESTINAL VIDEOSCOPE SYSTEM

Applicant Olympus Medical Systems Corporation

K number K051551

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KNT 2005-05-27

PROCON2

Applicant Incontinent Control Devices, Inc.

K number K042431

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KNT 2005-05-11

WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE

Applicant Wilson-Cook Medical, Inc.

K number K043203

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KNT 2005-05-06

ANTI-I.V. ENTERAL FEEDING SYSTEM

Applicant Viasys Medsystems

K number K043044

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KNT 2005-01-28

INFANT FEEDING TUBE

Applicant Marian Medical, Inc.

K number K042112

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KNT 2004-12-17

CORTRAK

Applicant Viasys Medsystems

K number K041987

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KNT 2004-12-16

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02

Applicant Teleflex Medical

K number K043258

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KNT 2004-12-10

KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE

Applicant Kimberly-Clark Corp.

K number K043114

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KNT 2004-12-02

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

Applicant Applied Medical Technology, Inc.

K number K043027

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KNT 2004-11-05

KENDALL CO2NFIRM NOW CO2 DETECTOR

Applicant Kendall

K number K042572

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KNT 2004-10-25

AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM

Applicant Applied Medical Technology, Inc.

K number K042300

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KNT 2004-08-31

SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)

Applicant Entracare, LLC

K number K041034

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KNT 2004-05-11

Y2K2 ENTERNAL FEEDING MANAGER

Applicant Moss Medical Products

K number K030413

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KNT 2004-04-08

CONVATEC FECAL MANAGEMENT SYSTEM

Applicant Convatec, A Bristol-Myers Squibb Co.

K number K032734

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KNT 2004-04-01

NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL

Applicant Applied Medical Technology, Inc.

K number K030784

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KNT 2004-02-05

MOSSMED DUAL INTERMITTENT ASPIRATOR

Applicant Moss Medical Products

K number K031492

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KNT 2003-12-12

FASTRAC GASTRIC ACCESS PORT KIT

Applicant C.R. Bard, Inc.

K number K033562

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KNT 2003-07-11

COOK GASTRIC SIZING BALLOON CATHETER

Applicant Cook, Inc.

K number K030841

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KNT 2003-07-08

NGT

Applicant Medical Innovative Products

K number K022558

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KNT 2003-06-27

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

Applicant Boston Scientific Corp

K number K031538

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KNT 2003-04-17

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

Applicant Boston Scientific Corp

K number K030855

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KNT 2003-04-03

FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

Applicant Fortune Medical Instrument Corp.

K number K022112

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KNT 2002-11-06

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE

Applicant Bowel Management Systems, LLC

K number K023344

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KNT 2002-09-05

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

Applicant Boston Scientific Corp

K number K022648

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KNT 2002-08-30

ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S

Applicant Andersen Products, Inc.

K number K021493

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KNT 2002-08-02

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

Applicant Boston Scientific Corp

K number K020120

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KNT 2002-07-18

MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE

Applicant Syncro Medical Innovations, Inc.

K number K021991

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KNT 2002-07-16

INFANT FEEDING TUBES

Applicant Promedic, Inc.

K number K020005

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KNT 2002-07-09

ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P

Applicant Boston Scientific Corp

K number K014297

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KNT 2002-06-26

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

Applicant Tfx Medical, Inc.

K number K021034

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KNT 2002-06-25

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

Applicant Tfx Medical, Inc.

K number K020985

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KNT 2002-05-06

PPD BALLOON DILATATION CATHETER

Applicant Telemed Systems, Inc.

K number K020379

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KNT 2002-05-03

INDWELLING FECAL MANAGEMENT SYSTEM

Applicant Bowel Management Systems, LLC

K number K012113

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KNT 2002-02-26

RUSCH CANTOR TUBE

Applicant Rusch Intl.

K number K010798

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KNT 2002-02-26

RUSCH MILLER-ABBOTT TUBE

Applicant Rusch Intl.

K number K010797

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KNT 2001-11-02

DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE

Applicant Zevex, Inc.

K number K012147

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KNT 2001-10-19

14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH

Applicant Medcomp

K number K013162

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KNT 2001-10-19

DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W

Applicant C.R. Bard, Inc.

K number K013144

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KNT 2001-09-21

LH 500 ENTERAL FEEDING GRAVITY BAG SET

Applicant Lh Medical Products, Inc.

K number K011343

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KNT 2001-09-21

LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET

Applicant Lh Medical Products, Inc.

K number K011341

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KNT 2001-09-21

LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT

Applicant Lh Medical Products, Inc.

K number K011340

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KNT 2001-08-31

MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010

Applicant Applied Medical Technology, Inc.

K number K012476

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KNT 2001-08-10

ROSS EMBRACE PUMP SET

Applicant Ross Products

K number K011467

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KNT 2001-07-09

GASTRIC SUCTION AND DRAINAGE CATHETER

Applicant Bioenterics Corp.

K number K002838

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KNT 2001-05-09

ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)

Applicant Andersen Products, Inc.

K number K011077

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KNT 2001-02-16

COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX

Applicant Novartis Nutrition Corp.

K number K001916

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KNT 2000-07-26

GASTRIC LAVAGE VALVE

Applicant T-Med Vac Corporation

K number K990365

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KNT 2000-03-15

SIGHTSURE OPERATION INDICATOR, MODEL SS301

Applicant Medevices, Inc.

K number K993358

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KNT 2000-02-10

NASOGASTRIC TUBE HOLDER, MODEL 160

Applicant Dale Medical Products, Inc.

K number K994300

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KNT 2000-01-12

AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE

Applicant Amsino Intl., Inc.

K number K992719

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KNT 1999-12-15

TRIP TONOMETRY CATHETER, 14F

Applicant Datex-Ohmeda, Inc.

K number K993296

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KNT 1999-10-29

NUTRISAFE EXTENSION TUBE

Applicant Vygon Corp.

K number K991918

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KNT 1999-10-20

BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT

Applicant Ballard Medical Products

K number K993138

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KNT 1999-09-10

BARD BALLOON INFLATION SYSTEM

Applicant C.R. Bard, Inc.

K number K991375

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KNT 1999-08-25

FLEXIFLO ENTERAL FEEDING TUBE

Applicant Ross Product Div. Abbott Laboratories

K number K992494

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KNT 1999-08-24

TRIP TONOMETRY CATHETER, 8F

Applicant Datex-Ohmeda, Inc.

K number K992181

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KNT 1999-07-26

COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)

Applicant Novartis Nutrition Corp.

K number K991668

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