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FDA 510(k) Application Details - K131303
Device Classification Name
Staple, Implantable
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510(K) Number
K131303
Device Name
Staple, Implantable
Applicant
CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO.
12226 WASHINGTON LANE
PARKER, AZ 85344 US
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Contact
CHARLIE MACK
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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
05/07/2013
Decision Date
06/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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