Dialyzer, High Permeability With Or Without Sealed Dialysate System

FDA product code KDI · 332 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5860
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1978-12-20 – 2026-07-24

KDI 1998-08-11

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

Applicant Gambro Healthcare

K number K981681

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KDI 1998-07-10

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

Applicant Baxter Healthcare Corp

K number K974652

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KDI 1998-06-26

DIALOG DIALYSIS MACHINE

Applicant B. Braun Medical AG

K number K963440

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KDI 1998-05-19

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236

Applicant Baxter Healthcare Corp

K number K980656

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KDI 1998-05-14

FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

Applicant Fresenius USA, Inc.

K number K974584

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KDI 1998-05-12

HEMOCOR HPH MINI HEMOCONCENTRATOR

Applicant Minntech Corp.

K number K980859

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KDI 1998-01-30

CAPIOX HEMOCONCENTRATOR

Applicant Terumo Medical Corp.

K number K973516

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KDI 1997-09-26

COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET

Applicant Gambro Healthcare

K number K970253

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KDI 1997-09-09

BLOOD MONITOR PUMP

Applicant Baxter Healthcare Corp

K number K970591

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KDI 1997-07-24

BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT

Applicant C.R. Bard, Inc.

K number K971180

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KDI 1997-07-08

RMI HEMOCONCENTRATOR PREFERENCE PACK

Applicant Research Medical, Inc.

K number K970739

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KDI 1997-07-03

2008H ON LINE CLEARANCE MONITOR

Applicant Fresenius USA, Inc.

K number K961465

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KDI 1997-06-02

DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K970446

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KDI 1997-05-21

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K964922

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KDI 1997-04-30

COBE CENTRYSYSTEM 14 PES HEMODIALYZERS

Applicant Cobe Renal Care, Inc.

K number K955592

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KDI 1997-04-18

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS

Applicant Cobe Renal Care, Inc.

K number K955487

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KDI 1997-03-25

BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT

Applicant Baxter Healthcare Corp

K number K963203

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KDI 1997-03-19

NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS

Applicant NIKKISO CO., LTD.

K number K953996

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KDI 1997-02-10

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

Applicant Cobe Renal Care, Inc.

K number K946279

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KDI 1997-01-10

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K955384

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KDI 1996-10-09

MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET

Applicant Minntech Corp.

K number K962707

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KDI 1996-09-20

COBE CENTRYSYSTEM 700 HG HEMODIALYZER

Applicant Gambro Healthcare

K number K962427

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KDI 1996-08-14

COBE CENTRYSYSTEM 600 HG HEMODIALYZERS

Applicant Cobe Renal Care, Inc.

K number K960474

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KDI 1996-08-08

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K954987

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KDI 1996-01-11

GAMBRO HC 14R HEMOCONCENTRATOR

Applicant Cobe Renal Care, Inc.

K number K951311

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KDI 1995-10-05

ALTR NOVA 110 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K952983

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KDI 1995-10-05

ALTREX 110 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K952982

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KDI 1995-10-05

ALTRA FLUX 110 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K952978

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KDI 1995-09-15

GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS

Applicant Cobe Renal Care, Inc.

K number K952342

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KDI 1995-09-08

GAMBRO LUNDIA 94-600 DIALYZER

Applicant Cobe Renal Care, Inc.

K number K945747

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KDI 1995-08-15

RMI HEMOCONCENTRATOR

Applicant Research Medical, Inc.

K number K951344

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KDI 1995-06-22

FILTRYZER

Applicant Toray Industries (America), Inc.

K number K942681

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KDI 1995-05-30

ALTRA NOVA(TM) 140 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945625

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KDI 1995-05-30

ALTRA NOVA(TM) 170 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945621

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KDI 1995-05-23

ALTRA FLUX(TM) 170 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945542

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KDI 1995-05-18

ALTRA FLUX(TM) 140 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945620

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KDI 1995-04-27

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER

Applicant Baxter Healthcare Corp

K number K950522

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KDI 1995-03-13

GAMBRO FH 66 D HEMOFILTER

Applicant Cobe Renal Care, Inc.

K number K933883

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KDI 1995-03-08

ALTRES(R) 170 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945597

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KDI 1995-03-08

ALTRES(R) 140 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945596

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KDI 1995-03-08

ALTREX(R) 200 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K945595

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KDI 1995-02-13

ALTRA NOVA 200 HEMODAILYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K926379

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KDI 1995-02-13

ALTRA FLUX 200 HEMODIALYZER

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K926373

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KDI 1995-01-25

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

Applicant C.G.H. Medical, Inc.

K number K933818

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KDI 1994-09-30

BAXTER CT DIALYZER

Applicant Baxter Healthcare Corp

K number K926568

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KDI 1994-08-05

FILTRAL HEMODIALYZERS

Applicant C.G.H. Medical, Inc.

K number K920757

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KDI 1994-07-29

PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000

Applicant Minntech Corp.

K number K923727

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KDI 1994-07-07

LUNDIA ALPHA 700 HEMODIALYZER

Applicant C.G.H. Medical, Inc.

K number K931720

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KDI 1994-06-27

HEMOSPAL KIT B22 / MULTIFLOW 60 KIT

Applicant C.G.H. Medical, Inc.

K number K924437

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KDI 1994-02-18

HIGH PERMEABILITY DIALYER

Applicant Minntech Corp.

K number K923312

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KDI 1994-02-18

HEMOCOR HP HEMOCONCENTRATOR SERIES

Applicant Minntech Corp.

K number K923139

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KDI 1993-12-02

FRESENIUS POLYSULFONE DIALYZERS

Applicant Fresenius USA, Inc.

K number K921134

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KDI 1992-03-20

MODIFIED ASAHI PAN-SERIES HEMOFILTERS

Applicant Asahi Medical Co., Ltd.

K number K914020

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KDI 1992-03-16

PERITONEAL DIALYSIS CYCLER SET

Applicant National Medical Care, Medical Products Div., Inc.

K number K914363

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KDI 1991-11-01

DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY

Applicant Althin Medical AB an Affiliate of Baxter Intl

K number K913950

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KDI 1991-08-07

HEMOSPAL KIT B22

Applicant C.G.H. Medical, Inc.

K number K911603

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KDI 1991-04-16

INPERSOL CAPD BIOCAP ADMINISTRATION SET

Applicant Abbott Laboratories

K number K911094

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KDI 1991-04-09

RENAFLO HDF 1350 HEMODIAFILTER

Applicant Minntech Corp.

K number K910236

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KDI 1990-11-09

QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q

Applicant Bentley Laboratories, Inc.

K number K903641

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KDI 1990-11-01

AMICON DIAFILTER 30 HEMOCONCENTRATOR

Applicant Amicon, Inc.

K number K902837

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KDI 1990-07-27

HOLLOW FIBER DIALYZER, BIO CARE PS 130

Applicant National Medical Care, Medical Products Div., Inc.

K number K900018

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KDI 1990-07-16

GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER

Applicant Gambro, Inc.

K number K900918

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KDI 1990-05-18

AMICON HEMOCONCENTRATOR SET

Applicant Amicon, Inc.

K number K901286

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KDI 1990-01-11

AMICON MINIFILTER PLUS HEMOFILTER

Applicant Amicon, Inc.

K number K895405

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KDI 1989-11-08

HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H

Applicant National Medical Care, Medical Products Div., Inc.

K number K895759

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KDI 1989-07-24

FILTRAL TM 20 HEMODIALYZER/FILTER

Applicant Hospal Medical Corp.

K number K893742

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KDI 1989-04-25

FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M

Applicant Fresenius USA, Inc.

K number K892262

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KDI 1989-02-27

TORAY FILTRYZER BK SERIES

Applicant Toray Industries (America), Inc.

K number K883407

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KDI 1989-02-08

CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G

Applicant Baxter Healthcare Corp

K number K890315

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KDI 1988-12-08

MULTIFLOW(TM) 60 KIT

Applicant Hospal Medical Corp.

K number K884365

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KDI 1988-12-08

ULTRX(TM) 850 ARTIFICIAL KIDNEY

Applicant Cd Medical, Inc.

K number K884353

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KDI 1988-12-05

FILTRAL TM 8 HEMODIALYZER

Applicant Hospal Medical Corp.

K number K884326

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KDI 1988-10-12

CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT

Applicant Hospal Medical Corp.

K number K883307

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KDI 1988-09-13

FRESENIUS F8 DIALYZER

Applicant Fresenius USA, Inc.

K number K883195

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KDI 1987-12-29

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER

Applicant Hospal Medical Corp.

K number K872767

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KDI 1987-12-09

MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.

Applicant W.R. Grace & Co.-Conn.

K number K873887

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KDI 1987-09-15

HEMOCOR PLUS HEMOCONCENTRATOR

Applicant Minntech Corp.

K number K872456

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KDI 1987-05-15

GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER

Applicant Gambro, Inc.

K number K871108

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KDI 1987-04-01

FRESENIUS HEMOFLOW F60 AND F80

Applicant Seratronics, Inc.

K number K870724

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KDI 1987-03-03

FRESENIUS ULTRAFLUX AV400, AV600

Applicant Seratronics, Inc.

K number K864587

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KDI 1986-12-17

HOSPAL BIOSPAL 1800S

Applicant Hospal Medical Corp.

K number K863961

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KDI 1986-11-06

FRESENIUS HEMOFLOW F50 & F70

Applicant Seratronics, Inc.

K number K864169

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KDI 1986-11-06

AMICON DIAFILTER HEMOFILTER

Applicant Amicon, Inc.

K number K863823

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KDI 1986-06-19

HIGH EFFICIENCY HEMODIALYSIS SYSTEM

Applicant Travenol Laboratories, S.A.

K number K861776

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KDI 1986-04-07

FRESENIUS HEMOFLOW F80 DIALYZER

Applicant Seratronics, Inc.

K number K861106

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KDI 1986-04-07

GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS

Applicant Gambro, Inc.

K number K860938

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KDI 1986-02-04

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS

Applicant Advocacy International, Ltd.

K number K855251

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KDI 1985-12-13

HOLLOW FIBER DIALYZER

Applicant Travenol Laboratories, S.A.

K number K854586

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KDI 1985-12-13

GAMBRO BLOOD CONCENTRATOR SETS 16,60,200

Applicant Gambro, Inc.

K number K854309

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KDI 1985-11-05

RENALFO HEMOFILTER CAVHD

Applicant Renal Systems, Inc.

K number K854011

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KDI 1985-09-12

MINIFILTER HEMOFILTER

Applicant Amicon, Inc.

K number K853510

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KDI 1985-09-06

FILTRAL HEMODIALYZER

Applicant Hospal Medical Corp.

K number K852885

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KDI 1985-09-03

DIMENSION TOTAL HIP PROSTHESIS

Applicant Kirschner Medical Corp.

K number K853333

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KDI 1985-07-29

HEMOCONCENTRATOR KIT

Applicant Omnis Surgical, Inc.

K number K850979

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KDI 1985-07-25

FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40

Applicant Seratronics, Inc.

K number K852251

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KDI 1985-05-23

RENAFLO HEMOCONCENTRATOR

Applicant Renal Systems, Inc.

K number K844790

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KDI 1985-04-03

TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L

Applicant Erika, Inc.

K number K850866

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KDI 1985-01-18

ASAHI NEW PAN-SERIES HEMOFILTERS

Applicant Asahi Medical Co., Ltd.

K number K844663

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KDI 1984-10-18

FRESENIUS HAEMODIALYSIS A2008

Applicant Seratronics, Inc.

K number K843014

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KDI 1984-10-18

AMER. BENTLEY CONTINU-BLOOD PROCESSOR-

Applicant American Bentley

K number K841585

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