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510(k) K892523

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY by Gambro, Inc. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
April 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K032431 — PRISMA M60/M100 SETS (September 15, 2003)
  • K896758 — GAMBRO BICARBONATE MONITOR BCM 10-3 (September 28, 1990)
  • K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS (August 30, 1990)
  • K902481 — GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER (July 27, 1990)
  • K900918 — GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER (July 16, 1990)
  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)
  • K890111 — GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER (February 8, 1989)

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  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)