FDA 510(k) Application Details - K012268

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K012268
Device Name	Gown, Surgical
Applicant	STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. CINCINNATI, OH 45237-1600 US Other 510(k) Applications for this Company
Contact	BRADLEY J BUSHMAN 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	07/19/2001
Decision Date	12/03/2001
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