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FDA 510(k) Application Details - K140170
Device Classification Name
Staple, Implantable
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510(K) Number
K140170
Device Name
Staple, Implantable
Applicant
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY, CA 94063 US
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Contact
VEE ARYA
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Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
01/23/2014
Decision Date
02/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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