FDA 510(k) Application Details - K080627

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K080627
Device Name	Gown, Surgical
Applicant	PROMEDICAL PRODUCTS CO., LTD. # 206 HAUNG HE ROAD WEST CHANGZHOU, JIANGSU 213022 CN Other 510(k) Applications for this Company
Contact	LEO WEI 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	03/05/2008
Decision Date	04/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review