FDA 510(k) Application Details - K040485

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K040485
Device Name	Gown, Surgical
Applicant	BIO-MEDICAL DEVICES, INC. 17171 DAIMLER AVE. IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	NICK HERBERT 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	02/25/2004
Decision Date	10/18/2004
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