FDA 510(k) Application Details - K100386

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K100386
Device Name	Staple, Implantable
Applicant	CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN ROAD (S-2) SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	02/16/2010
Decision Date	03/01/2010
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