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510(k) K901368

HEMOSPAL KITS A1, A2D, AO, & A1D by Gambro-Hospal, Inc. — Product Code FJG

K901368 is an FDA 510(k) premarket notification submitted by Gambro-Hospal, Inc. for the device "HEMOSPAL KITS A1, A2D, AO, & A1D". The FDA issued a decision of Substantially Equivalent on August 2, 1990. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Gambro-Hospal, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1990
Date Received
March 23, 1990
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 Gambro-Hospal, Inc.

  • K902588 — BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD (March 7, 1991)
  • K896068 — TIPSTOP(TM) (September 10, 1990)

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)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • 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