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FDA 510(k) Application Details - K142577
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K142577
Device Name
Staple, Implantable
Applicant
B.J.Z.H.F. Panther Medical Equipment Co. Ltd.
ROM 805, Ruichuang Mansion, NO. 9 Wangjing East
Beijing CN
Other 510(k) Applications for this Company
Contact
Liu Yu
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/12/2014
Decision Date
06/11/2015
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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