FDA 510(k) Application Details - K091097

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K091097
Device Name	Gown, Surgical
Applicant	PROMEDICAL PRODUCTS CO., LTD. 5165 BROADWAY SUITE 116 DEPEW, NY 14043-4012 US Other 510(k) Applications for this Company
Contact	DAVID POWER 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	04/16/2009
Decision Date	05/27/2009
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