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FDA 510(k) Application Details - K965016
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K965016
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS, IN 46236 US
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Contact
BILL BRILEY
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Regulation Number
868.5260
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Classification Product Code
CAH
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More FDA Info for this Product Code
Date Received
12/16/1996
Decision Date
12/02/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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