FDA 510(k) Application Details - K122000

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K122000
Device Name	Drape, Surgical
Applicant	CHANGZHOU HOLYMED PRODUCTS CO LTD 528 CHANGWU ROAD SOUTH WUJIN DISTRICT CHANGHOU 213167 CN Other 510(k) Applications for this Company
Contact	ALAN YU Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2012
Decision Date	12/12/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review