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FDA 510(k) Application Details - K073304
Device Classification Name
Clip, Implantable
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510(K) Number
K073304
Device Name
Clip, Implantable
Applicant
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY, CA 94063 US
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Contact
ISKRA MRAKOVIC
Other 510(k) Applications for this Contact
Regulation Number
878.4300
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Classification Product Code
FZP
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More FDA Info for this Product Code
Date Received
11/23/2007
Decision Date
12/20/2007
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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