FDA 510(k) Application Details - K103470

Device Classification Name Staple, Implantable

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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
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Regulation Number 878.4750

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Classification Product Code GDW
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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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