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510(k) K883589

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER by Gambro, Inc. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1988
Date Received
August 22, 1988
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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  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

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