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510(k) K915504

GAMBRO LUNDIA ALPHA HEMODIALYZERS by C.G.H. Medical, Inc. — Product Code FJG

K915504 is an FDA 510(k) premarket notification submitted by C.G.H. Medical, Inc. for the device "GAMBRO LUNDIA ALPHA HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on March 6, 1992. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. C.G.H. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1992
Date Received
December 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by C.G.H. Medical, Inc.

  • K941708 — COBE CENTRYSYSTEM CS500 DIALYZER (May 12, 1995)
  • K933818 — GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER (January 25, 1995)
  • K925522 — CENTRYSYSTEM 3 WITH CHARTS/BP OPTION (September 30, 1994)
  • K920757 — FILTRAL HEMODIALYZERS (August 5, 1994)
  • K931720 — LUNDIA ALPHA 700 HEMODIALYZER (July 7, 1994)
  • K924437 — HEMOSPAL KIT B22 / MULTIFLOW 60 KIT (June 27, 1994)
  • K940601 — GAMBRO BICART 720G (March 22, 1994)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)
  • K914271 — GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (April 13, 1992)
  • K911603 — HEMOSPAL KIT B22 (August 7, 1991)

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (September 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (August 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (August 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (September 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (January 8, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
  • K812336 — COBE PPD 1.9 (August 31, 1981)
  • K811439 — EXP 200 PARALLEL PLATE DIALYZER (June 12, 1981)

FDA data resources