FDA 510(k) Application Details - K042654

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K042654
Device Name	Mask, Surgical
Applicant	SAFETY-MED PRODUCTS, INC. 140 LONGMEADOW DRIVE BURLINGTON, WI 53105 US Other 510(k) Applications for this Company
Contact	CHRIS WAGNER Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2004
Decision Date	12/17/2004
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