FDA 510(k) Application Details - K152618

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K152618
Device Name	Staple, Implantable
Applicant	B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD ROOM 3305A, FLOOR 3, BLDG 3, NO.208 BLOCK 2 LIZA PARK, WANGJING INDUSTRIAL DIST. BEIJING 100102 CN Other 510(k) Applications for this Company
Contact	LINA YUN 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	09/14/2015
Decision Date	11/12/2015
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