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510(k) K880084

GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS by Gambro, Inc. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1988
Date Received
January 12, 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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