Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Pump, Infusion

FDA product code FRN · 840 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-23 – 2026-07-24

FRN 2000-08-01

ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS

Applicant Alaris Medical Systems, Inc.

K number K993524

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FRN 2000-07-28

COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151

Applicant Baxter Healthcare Corp

K number K002211

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FRN 2000-07-20

ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP

Applicant Abbott Laboratories

K number K002126

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FRN 2000-06-21

DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

Applicant Disetronic Medical Systems AG

K number K001629

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FRN 2000-06-08

CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

Applicant Sims Deltec, Inc.

K number K000842

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FRN 2000-05-31

QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)

Applicant Quest Medical, Inc.

K number K994274

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FRN 2000-05-09

MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP

Applicant Medex, Inc.

K number K000328

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FRN 2000-03-24

ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION

Applicant Abbott Laboratories

K number K000821

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FRN 2000-03-08

HORIZON LIGHT

Applicant B.Braun Medical, Inc.

K number K994375

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FRN 2000-03-03

SOAKER CATHETER

Applicant I-Flow Corp.

K number K994374

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FRN 2000-02-22

SIMS PORTEX ANESTHESIA CATHETER

Applicant Sims Portex, Inc.

K number K994275

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FRN 2000-01-18

3.0 ML RESERVOIR, MODEL 103/193

Applicant Medtronic Minimed

K number K991936

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FRN 1999-12-22

ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB

Applicant Abbott Laboratories

K number K994039

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FRN 1999-11-01

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K

Applicant Baxter Healthcare Corp

K number K993387

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FRN 1999-10-15

IRRIGATION OR INFUSION PUMP K PUMP

Applicant Kmi Kolster Methods, Inc.

K number K991203

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FRN 1999-09-08

INFUSION DYNAMICS POWER INFUSER MODEL M100B

Applicant Infusion Dynamics, Inc.

K number K992044

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FRN 1999-08-30

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00

Applicant Wells Johnson Co.

K number K991437

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FRN 1999-08-24

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

Applicant Belmont Instrument Corp.

K number K992672

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FRN 1999-07-01

WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS

Applicant Mckinley, Inc.

K number K991275

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FRN 1999-06-23

MINIMED 407C INFUSION PUMP, MODEL 407C

Applicant Medtronic Minimed

K number K991013

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FRN 1999-05-13

ACCLAIM INFUSION PUMP

Applicant Abbott Laboratories

K number K991501

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FRN 1999-05-13

30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU

Applicant Sorenson Medical, Inc.

K number K991363

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FRN 1999-05-12

1000 PRESSURE INFUSION SIGMACON 1000

Applicant Valley West, Inc.

K number K990447

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FRN 1999-04-23

SIDEKICK INFUSION KIT

Applicant I-Flow Corp.

K number K990425

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FRN 1999-04-06

MEDEX 3000 SERIES SYRINGE INFUSION PUMP

Applicant Medex, Inc.

K number K982640

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FRN 1999-03-25

PEREGRINE WET SET, MODEL PD400.00

Applicant Peregrine Surgical , Ltd.

K number K990518

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FRN 1999-03-19

PAIN CONTROL INFUSION PUMP

Applicant Sgarlato Laboratories, Inc.

K number K990101

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FRN 1999-02-24

SABRATEK 4040 INFUSION PUMP

Applicant Sabratek Corp.

K number K980751

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FRN 1999-02-12

DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

Applicant Disetronic Medical Systems

K number K990259

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FRN 1999-02-04

PERFUSOR COMPACT

Applicant B.Braun Medical, Inc.

K number K983005

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FRN 1999-01-12

ABBOTT PLUM A+ INFUSION PUMP

Applicant Abbott Laboratories

K number K982159

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FRN 1998-12-29

VARIABLE PRESSURE SYRINGE PUMP

Applicant Alaris Medical Systems, Inc.

K number K974332

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FRN 1998-12-09

MELODIE INFUSION PUMP

Applicant Compagnie DE Developpement Aguettant

K number K980378

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FRN 1998-12-04

CUE AMBULATORY VOLUMETRIC INFUSION PUMP

Applicant Becton Dickinson Curlin, LLC

K number K981816

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FRN 1998-11-30

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

Applicant Belmont Instrument Corp.

K number K983975

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FRN 1998-11-30

FLUIDSENSE FLUID DELIVERY SYSTEM

Applicant Fluidsense Corp.

K number K982170

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FRN 1998-11-20

ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP

Applicant Abbott Laboratories

K number K983838

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FRN 1998-11-04

CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400

Applicant Sims Deltec, Inc.

K number K982838

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FRN 1998-11-02

CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM

Applicant Sims Deltec, Inc.

K number K982836

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FRN 1998-10-06

MICROFUSE DUAL RATE INFUSER

Applicant Baxa Corp.

K number K983321

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FRN 1998-09-30

METRON QA-IDS I.V. PUMP TESTER

Applicant Metron U.S., Inc.

K number K982020

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FRN 1998-08-25

BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5

Applicant Bridge Medical, Inc.

K number K973593

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FRN 1998-08-03

ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X

Applicant Alexander Mfg. Co.

K number K981776

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FRN 1998-06-16

PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION

Applicant Byron Medical

K number K980738

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FRN 1998-03-24

3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000

Applicant Valley West, Inc.

K number K980089

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FRN 1998-03-17

ABBOTT GEMSTAR IV INFUSION PUMP

Applicant Abbott Laboratories

K number K974778

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FRN 1998-03-09

SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS

Applicant Smith & Nephew, Inc.

K number K980092

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FRN 1998-01-09

CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM

Applicant Sims Deltec, Inc.

K number K973917

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FRN 1998-01-05

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630

Applicant Alexander Mfg. Co.

K number K973851

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FRN 1997-12-18

IDA-4 AND IPT-MC

Applicant Bio-Tek Instruments, Inc.

K number K973609

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FRN 1997-11-13

FLUID MANAGEMENT SYSTEM

Applicant Belmont Instrument Corp.

K number K972284

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FRN 1997-10-07

MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS

Applicant Mcgaw, Inc.

K number K972678

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FRN 1997-09-12

BIG BAG 3000 PRESSURE INFUSOR

Applicant Byron Medical

K number K973133

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FRN 1997-07-18

PULSE*SPRAY INJECTOR

Applicant AngioDynamics, Inc.

K number K963574

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FRN 1997-07-03

ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP

Applicant Abbott Mfg., Inc.

K number K965230

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FRN 1997-02-26

MODELS IDA-2 PLUS AND IPT-1

Applicant Bio-Tek Instruments, Inc.

K number K961862

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FRN 1997-01-30

DISETRONIC D-MODEM

Applicant Disetronic Medical Systems

K number K961975

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FRN 1996-11-21

GEMINI PC-ITX

Applicant Imed Corp.

K number K960512

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FRN 1996-10-07

SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/

Applicant Sigma Intl.

K number K962709

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FRN 1996-08-23

MODEL 1200 ABMULATORY INFUSION PUMP

Applicant Patient Solutions, Inc.

K number K961263

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FRN 1996-08-23

CADD-PRIZM MODEL 6100 PUMP

Applicant Sims Deltec, Inc.

K number K960826

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FRN 1996-07-18

MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP

Applicant Medex, Inc.

K number K955231

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FRN 1996-07-08

COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)

Applicant Baxter Healthcare Corp

K number K961703

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FRN 1996-06-04

EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK

Applicant Sims Deltec, Inc.

K number K960957

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FRN 1996-06-03

3030 INFUSION PUMP

Applicant Sabratek Corp.

K number K955258

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FRN 1996-05-24

DISETRONIC MULTIFUSE PUMP SYSTEM

Applicant Disetronic Medical Systems

K number K954826

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FRN 1996-05-23

CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP

Applicant Sims Deltec, Inc.

K number K955180

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FRN 1996-03-20

THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS

Applicant Imed Corp.

K number K953896

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FRN 1996-02-09

UNIMED MEDICAL DISPENSING PUMP

Applicant A.Z.E. Medical, Inc.

K number K952967

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FRN 1996-01-18

ABBOTT XL3M INFUSION PUMP

Applicant Abbott Laboratories

K number K952799

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FRN 1995-12-22

VOLUMETRIC INFUSION PUMP

Applicant Baxter Healthcare Corp

K number K953098

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FRN 1995-12-13

PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)

Applicant Abbott Laboratories

K number K953731

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FRN 1995-11-15

SMARTDOSE III INFUSION CONTAINER

Applicant River Medical, Inc.

K number K944352

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FRN 1995-11-15

SMARTDOSE IV PREFILLED INFUSION CONTAINER

Applicant River Medical, Inc.

K number K944351

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FRN 1995-10-17

PLUM XL INFUSION PUMP (MODIFICATION)

Applicant Abbott Laboratories

K number K953660

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FRN 1995-10-17

ACCUPUMP 901 (MODEL NUMBERS 50 & 100)

Applicant Pharmaceutical Infusion Technologies, Inc.

K number K953382

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FRN 1995-10-07

MODEL 1100 MEDMATE INFUSION PUMP

Applicant Patient Solutions, Inc.

K number K953270

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FRN 1995-10-07

DISETRONIC D-MODEM

Applicant Disetronic Medical Systems

K number K943952

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FRN 1995-09-19

ADI SYSTEM

Applicant Abbott Laboratories

K number K933825

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FRN 1995-09-15

HARVARD 2 SYRINGE PUMP

Applicant Harvard Apparatus, Inc.

K number K952794

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FRN 1995-08-11

9000 INFUSION PUMP

Applicant Graseby Medical , Ltd.

K number K944721

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FRN 1995-07-24

FLEXIFLO QUANTUM ENTERAL PUMP

Applicant Abbott Mfg., Inc.

K number K944669

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FRN 1995-07-10

AUTO SYRINGE(R) AS50 INFUSION PUMP

Applicant Baxter Healthcare Corp

K number K945942

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FRN 1995-06-21

THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS

Applicant Imed Corp.

K number K950419

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FRN 1995-06-19

CORFLO 300 PUMP

Applicant Corpak, Inc.

K number K944750

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FRN 1995-05-23

LIFECARE 175 INFUSER, MODIFICATION

Applicant Abbott Laboratories

K number K944190

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FRN 1995-04-28

SMART DOSE(TM)

Applicant River Medical, Inc.

K number K943692

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FRN 1995-03-22

SIGMA 8000 AND SIGMA 8002

Applicant Sigma Intl. General Medical Apparatus, Inc.

K number K950766

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FRN 1995-03-01

POCKET PUMP

Applicant Baxa Infusion Systems

K number K942378

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FRN 1995-02-08

PLUM XL INFUSION PUMP

Applicant Abbott Laboratories

K number K944733

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FRN 1994-12-19

MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5

Applicant Microject, Inc.

K number K941595

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FRN 1994-12-09

3400 INFUSION PUMP

Applicant Graseby Medical , Ltd.

K number K931318

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FRN 1994-12-06

ABBOTT LTE INFUSION PUMP

Applicant Abbott Laboratories

K number K944125

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FRN 1994-10-20

SIGMA 8000 AND SIGMA 8002

Applicant Sigma Intl.

K number K942162

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FRN 1994-09-29

SIEMENS FLUID DELIVERY SYSTEM, MMT-9500

Applicant Siemens Infusions Systems

K number K933545

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FRN 1994-08-15

3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)

Applicant Minnesota Mining and Mfg. Co.

K number K940446

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FRN 1994-08-02

LOCKBOX

Applicant Pharmacia Deltec, Inc.

K number K942161

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FRN 1994-07-19

SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP

Applicant Sabratek Corp.

K number K941984

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FRN 1994-07-13

PROVIDER ANNE INFUSER

Applicant Abbott Laboratories

K number K922702

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FRN 1994-07-07

STRATOFUSE PCA II INFUSER

Applicant Infusion Technology Intl.

K number K941151

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