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510(k) K904967

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL by Gambro-Hosp-Cobe, Inc. — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1991
Date Received
November 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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