Dialyzer, Parallel Flow

FDA product code FJG · 36 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1977-04-15 – 1994-09-07

FJG 1994-09-07

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS

Applicant Cobe Renal Care, Inc.

K number K933681

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FJG 1994-08-26

GAMBRO LUNDIA PRO 200 DIALYZER

Applicant Cobe Renal Care, Inc.

K number K933680

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FJG 1992-09-21

DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9

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

K number K920693

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FJG 1992-03-06

GAMBRO LUNDIA ALPHA HEMODIALYZERS

Applicant C.G.H. Medical, Inc.

K number K915504

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FJG 1990-08-02

HEMOSPAL KITS A1, A2D, AO, & A1D

Applicant Gambro-Hospal, Inc.

K number K901368

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FJG 1990-08-01

TENCKHOFF PERITONEAL DIALYSIS KIT

Applicant Akcess Medical Products, Inc.

K number K902203

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FJG 1986-09-29

GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N

Applicant Gambro, Inc.

K number K862840

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FJG 1986-01-08

GAMBRO LUNDIA PRO 3 & 5 DIALYZER

Applicant Gambro, Inc.

K number K853406

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FJG 1982-03-31

COBE PPD 1.3L, #18-520-009

Applicant Cobe Laboratories, Inc.

K number K820694

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FJG 1981-08-31

COBE PPD 1.9

Applicant Cobe Laboratories, Inc.

K number K812336

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FJG 1981-06-12

EXP 600 PARALLEL PLATE DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K811440

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FJG 1981-06-12

EXP 200 PARALLEL PLATE DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K811439

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FJG 1981-06-09

COBE PPD .8

Applicant Cobe Laboratories, Inc.

K number K810066

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FJG 1981-05-05

CYBER 80 HEMODIALYZER

Applicant Cyberex Corp.

K number K810837

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FJG 1981-03-20

CYBER 120 HEMODIALYZER

Applicant Cyberex Corp.

K number K802478

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FJG 1981-03-04

NIKKISO ND-14 PARALLEL FLOW DIALYZER

Applicant NIKKISO CO., LTD.

K number K803068

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FJG 1981-01-29

EXTRACORPOREAL'S EXP 400 PARALLEL PLATE

Applicant Extracorporeal Medical Specialities, Inc.

K number K802364

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FJG 1980-12-22

GAMBRO LUNDIA PLATE DISP. DIALYZER

Applicant Gambro, Inc.

K number K802389

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FJG 1980-12-18

THE BRAVO NEW PARALLEL FLOW DIALYZER

Applicant Bellco Artifidial Organ Spec., Inc.

K number K801633

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FJG 1980-09-26

ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM

Applicant Medical, Inc.

K number K801451

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FJG 1980-08-27

CYBER 120 HEMODIALYZER

Applicant Cyberex Corp.

K number K801377

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FJG 1980-04-10

LUNDIA PLATE DISP.

Applicant Gambro, Inc.

K number K800424

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FJG 1980-02-06

GAMBRO LUNDIA PLATE DIALYZER

Applicant Gambro, Inc.

K number K792611

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FJG 1979-11-13

EXTRACORPOREAL'S MODEL EX-85 DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K791961

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FJG 1979-08-07

HEMODIALYZERS RP-510 AND RP-514

Applicant Hospal Medical Corp.

K number K791448

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FJG 1979-05-08

HEMOCLEAR U-NEPHROS 1.0 DIALYZER

Applicant Medical, Inc.

K number K790758

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FJG 1979-05-02

HD CAPILLARY FILM DIALYZER, MODEL 1001

Applicant Travenol Laboratories, S.A.

K number K790533

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FJG 1979-03-06

DIALYZER, MODEL F.M.D 150

Applicant Hospal Medical Corp.

K number K790001

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FJG 1979-02-21

DIALYZER, MAGNIFLO 100 PARALLEL PLATE

Applicant Erika, Inc.

K number K781966

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FJG 1978-12-15