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510(k) K810127

GAMBRO BICARBONATE MODULE, BCM-10 by Gambro, Inc. — Product Code FKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1981
Date Received
January 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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