FDA 510(k) Application Details - K012240

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K012240
Device Name	Gown, Surgical
Applicant	MERCAN AB 10907 WAREHAM COURT AUSTIN, TX 78739 US Other 510(k) Applications for this Company
Contact	JEFFREY O STULL 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	07/17/2001
Decision Date	10/15/2001
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