FDA 510(k) Application Details - K042267

Device Classification Name	Respirator,Surgical   More FDA Info for this Device
510(K) Number	K042267
Device Name	Respirator,Surgical
Applicant	INOVEL LLC 10111 W. JEFFERSON BLVD. CULVER CITY, CA 90232-3509 US Other 510(k) Applications for this Company
Contact	WILLIAM WAWRZYNIAK Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	MSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2004
Decision Date	09/30/2004
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	Y
Expedited Review