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FDA 510(k) Application Details - K960511
Device Classification Name
System, Thermal Regulating
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510(K) Number
K960511
Device Name
System, Thermal Regulating
Applicant
GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS, IN 46236 US
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Contact
BRIAN GRIGSBY
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Regulation Number
870.5900
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Classification Product Code
DWJ
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More FDA Info for this Product Code
Date Received
02/05/1996
Decision Date
01/13/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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