FDA 510(k) Application Details - K111458

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K111458
Device Name	Drape, Surgical
Applicant	GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. 717 LAKEGLEN DRIVE SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	PENNY NORTHCUTT 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	05/26/2011
Decision Date	12/01/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review