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FDA 510(k) Application Details - K103470
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K103470
Device Name
Staple, Implantable
Applicant
B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD
ROOM 1606 BLDG. 1 JIANXIANG YU
NO. 209 BEI SI HUAN
BEIJING 100083 CN
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Contact
CHU XIAOAN
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
11/26/2010
Decision Date
01/11/2011
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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