FDA 510(k) Application Details - K121152

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K121152
Device Name	Gown, Surgical
Applicant	JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD 7305 HANCOCK VILLAGE DR SUITE 109 CHESTERFIELD, VA 23832 US Other 510(k) Applications for this Company
Contact	DARREN REEVES Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2012
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	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review