FDA 510(k) Application Details - K032631

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K032631
Device Name	Gown, Surgical
Applicant	LAC MAC, LTD. 10907 WAREHAM COURT AUSTIN, TX 78739 US Other 510(k) Applications for this Company
Contact	JEFRREY 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	08/26/2003
Decision Date	02/05/2004
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