Subsystem, Water Purification

FDA product code FIP · 111 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5665
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-10-04 – 2025-11-14

FIP 2025-11-14

AquaC UNO H

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K250471

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FIP 2025-10-09

DIASAFEplusUS (F00013010)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K251851

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FIP 2025-09-09

AquaA

Applicant Fresenius Medical Care North America

K number K252181

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FIP 2025-03-17

UPT Series Medical RO Water Treatment System

Applicant Specialty Water Technologies, Inc.

K number K250514

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FIP 2024-06-13

AquaBplus; AquaB LITE

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K232953

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FIP 2023-08-16

AQUAbase nX

Applicant B.Braun Medical, Inc.

K number K223479

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FIP 2023-07-19

RenaPure Endotoxin Retentive Filter

Applicant Evoqua Water Technologies, LLC

K number K231410

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FIP 2023-02-13

AmeriWater MediQA Reverse Osmosis System (MSP3HF)

Applicant AmeriWater, LLC

K number K223656

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FIP 2022-07-27

AquaA

Applicant Fresenius Medical Care Rental Therapies Group, LLC

K number K213507

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FIP 2021-10-19

U9000 Plus Ultrafilter

Applicant Baxter Healthcare Corporation

K number K211035

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FIP 2020-04-16

EON Portable RO Water Purification System

Applicant Mar Cor Purification, Inc.

K number K200670

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FIP 2019-10-03

Millenium HX

Applicant Mar Cor Purification, Inc.

K number K192398

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FIP 2019-01-10

DIASAFEplusUS

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K182367

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FIP 2018-01-05

EON Portable Reverse Osmosis Water Purification System

Applicant Cantel

K number K171099

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FIP 2017-03-02

EndoPur Filter

Applicant Nephros, Inc.

K number K161304

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FIP 2016-12-13

Matrix Pre-Treatment Controller

Applicant Better Water, LLC

K number K161844

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FIP 2016-08-04

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

Applicant Med-Tech Water Systems, Inc.

K number K153329

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FIP 2013-11-13

MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA

Applicant Ameriwater

K number K131904

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FIP 2013-09-20

MROZ REVERSE OSMOSIS SYSTEM

Applicant Ameriwater

K number K131622

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FIP 2013-04-25

DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS

Applicant Ultrapure & Industrial Services, LLC

K number K123282

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FIP 2013-03-25

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

Applicant Lauer Membran Wassertechnik GmbH

K number K124059

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FIP 2012-09-17

AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV

Applicant Ameriwater

K number K121022

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FIP 2012-07-05

BIOPURE PORTABLE RO SYSTEMS

Applicant Arion Water, Inc.

K number K112331

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FIP 2011-10-05

AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION

Applicant Ameriwater

K number K111740

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FIP 2011-07-14

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER

Applicant Nephros, Inc.

K number K110285

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FIP 2011-05-20

MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM

Applicant Mar Cor Purification, Inc.

K number K110578

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FIP 2011-02-03

ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

Applicant Aqua Sciences, Inc.

K number K102892

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FIP 2010-07-29

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

Applicant Gambro Renal Products, Inc.

K number K093608

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FIP 2010-04-02

HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2

Applicant New Aqua, LLC (Dba Aqua Systems)

K number K092481

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FIP 2009-07-10

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

Applicant Dipure, LLC

K number K083712

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FIP 2009-06-29

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER

Applicant Nephros, Inc.

K number K090885

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FIP 2009-02-03

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

Applicant Culligan Soft Water Service Co.

K number K082400

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FIP 2008-06-02

BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK

Applicant 4m Ventures, Inc.

K number K080703

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FIP 2008-02-21

AQUA PURE DEIONIZER EXCHANGE SERVICE

Applicant Staubach Barror Water Systems, Inc.

K number K072158

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FIP 2008-01-14

ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM

Applicant Flier'S Quality Water Systems, Inc.

K number K071104

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FIP 2007-01-04

GAMBRO POSICLEAR

Applicant Gambro Services, Inc.

K number K061782

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FIP 2006-07-07

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

Applicant Bob J. Johnson & Associates

K number K060942

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FIP 2005-11-18

MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES

Applicant Better Water, Inc.

K number K051620

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FIP 2005-04-15

ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM

Applicant Simply Clean Air & Water, Inc.

K number K042018

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FIP 2005-03-23

DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM

Applicant Dialysis Services, Inc.

K number K043344

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FIP 2005-03-09

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Gambro Renal Products

K number K042797

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FIP 2005-02-28

MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Mueller Water Conditioning, Inc.

K number K041884

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FIP 2004-11-24

NX STAGE WATER PURIFICATION SYSTEM

Applicant Nxstage Medical, Inc.

K number K042089

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FIP 2004-10-20

MEGA PURE CART

Applicant Mega Services

K number K031832

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FIP 2004-10-07

ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES

Applicant Isopure, Corp.

K number K041163

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FIP 2004-08-09

PERFORMANCE WATER TREATMENT SYSTEM

Applicant Performance Water Systems, LLC

K number K033648

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FIP 2003-10-21

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE

Applicant Biolab Equipment Canada , Ltd.

K number K030348

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FIP 2003-10-02

AQUABOSS ECORO DIA 50

Applicant Lauer Ltd., Hong Kong

K number K032004

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FIP 2003-09-03

MEDRO SPD

Applicant Usfilter/Ionpure, Inc.

K number K030652

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FIP 2003-08-14

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Ameriwater

K number K021560

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FIP 2003-05-28

WATER PURIFICATION SYSTEM

Applicant Purity Water Company of San Antonio, Inc.

K number K022448

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FIP 2003-04-07

PORTABLE RO+ MODEL MROS09

Applicant Ameriwater

K number K030059

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FIP 2003-02-11

HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM

Applicant Hydropure Systems, Inc.

K number K022747

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FIP 2002-11-01

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

Applicant Pure Water Solutions, Inc.

K number K011005

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FIP 2002-08-05

MPW HEMODIALYSIS WATER PURIFICATION SYSTEM

Applicant Mpw Industrial Water Services, Inc.

K number K001755

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FIP 2002-08-01

DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS

Applicant Dayton Water Systems

K number K021352

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FIP 2002-03-08

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM

Applicant Usfilter/Ionpure, Inc.

K number K013677

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FIP 2002-02-06

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

Applicant Bob J. Johnson & Assoc., Inc.

K number K014169

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FIP 2001-11-01

DIACLEAR ULTRAFILTER

Applicant Gambro Renal Products

K number K003957

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FIP 2001-09-28

AQUA WATER TREATMENT FOR HEMODIALYSIS

Applicant Aqua Water Treatment, Inc.

K number K010592

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FIP 2001-06-22

MAR COR SERVICES SEMPER PURE RO MACHINE

Applicant Mar Cor Services, Inc.

K number K003877

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FIP 2001-02-16

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Total Water Treatment Systems, Inc.

K number K002045

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FIP 2001-01-02

WATER PURIFICATION SYSTEM

Applicant Water & Power Technologies, Inc.

K number K994292

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FIP 2000-12-22

PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)

Applicant Pure Water Solutions, Inc.

K number K994279

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FIP 2000-12-15

AIW WATER SYSTEM FOR HEMODIALYSIS

Applicant American Industrial Water

K number K001282

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FIP 2000-12-11

SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100

Applicant Schaefer Water Centers

K number K000249

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FIP 2000-10-25

NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

Applicant Neu-Ion, Inc.

K number K001811

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FIP 2000-08-28

FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS

Applicant Fluid Process Systems, Inc.

K number K991495

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FIP 2000-08-14

DIALGUARD ENDOTOXIN REMOVAL DEVICE

Applicant Clarigen, Inc.

K number K993806

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FIP 2000-05-25

NELSON WATER SYSTEMS FOR HEMODIALYSIS

Applicant Nelson Environmental Technologies, Inc.

K number K993877

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FIP 2000-05-03

H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Serv-A-Pure Co.

K number K993520

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FIP 2000-04-14

AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Ameriwater

K number K991519

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FIP 2000-01-24

MD 420/440/460/470/480/490

Applicant Isopure, Corp.

K number K993200

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FIP 2000-01-24

PURE WATER, INC.'S WATER PURIFICATION SYSTEMS

Applicant Pure Water, Inc.

K number K992786

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FIP 2000-01-14

VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Virginia Water Systems, Inc.

K number K991916

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FIP 1999-11-18

WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS

Applicant Rasco

K number K983239

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FIP 1999-04-28

WATER TREATMENT SYSTEM FOR HEMODIALYSIS

Applicant Water Vault, Inc.

K number K983512

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FIP 1999-03-08

FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS

Applicant Minntech Corp.

K number K983126

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FIP 1998-12-31

ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS

Applicant Dayton Water Systems

K number K981680

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FIP 1998-11-16

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Usfilter/Ionpure, Inc.

K number K980182

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FIP 1998-09-23

GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H

Applicant Gambro Healthcare

K number K974899

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FIP 1998-05-18

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM

Applicant Gambro Healthcare

K number K981085

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FIP 1997-12-19

HYDRA METER

Applicant Automata Instrumentation, Inc.

K number K974127

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FIP 1997-11-26

PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST

Applicant Zyzatech Water Systems, Inc.

K number K964539

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FIP 1996-05-28

MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS

Applicant Mar Cor Services, Inc.

K number K945559

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FIP 1996-02-20

REVERSE OSMOSIS SYSTEM

Applicant G.E.M. Water Systems

K number K944493

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FIP 1996-01-24

PORTABLE REVERSE OSMOSIS MACHINE

Applicant Better Water, Inc.

K number K954928

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FIP 1995-12-15

FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS

Applicant Minntech Corp.

K number K954349

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FIP 1995-12-15

AWESMOSIS

Applicant Applied Water Engineering, Inc.

K number K945066

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FIP 1995-11-29

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER

Applicant Fresenius USA, Inc.

K number K944767

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FIP 1995-08-24

ASEPTECH PORTABLE RO+ SYSTEM

Applicant Dayton Water Systems

K number K924695

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FIP 1995-08-09

SERIM HISENSE TEST KIT

Applicant Serim Research Corp.

K number K952215

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FIP 1995-06-13

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Applicant Better Water, Inc.

K number K920186

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FIP 1995-04-28

MD400 A/B/C/D/E/F/G

Applicant International Purification Systems, Inc.

K number K944385

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FIP 1995-02-28

RENAGUARD DIALYSATE FILTER

Applicant Minntech Corp.

K number K945136

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FIP 1994-12-29

REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION

Applicant Osmonics, Inc.

K number K931595

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FIP 1994-09-29

MASTER ALERT

Applicant Master Hydro Systems, Inc.

K number K934848

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FIP 1993-07-02

SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM

Applicant Aqua-Med Systems, Inc.

K number K915258

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FIP 1990-03-13

SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS

Applicant U.S. Filter/Continental Water Systems

K number K894300

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FIP 1989-11-08

DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST

Applicant Cd Medical, Inc.

K number K894106

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