FDA 510(k) Application Details - K042111

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K042111
Device Name	Gown, Surgical
Applicant	PROMEDICAL PRODUCTS CO., LTD. 125 CLEMENTS AVE. STARKVILLE, MS 39759 US Other 510(k) Applications for this Company
Contact	BOYD HARRIS 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	08/05/2004
Decision Date	12/10/2004
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