FDA 510(k) Application Details - K100139

Device Classification Name	Respirator,Surgical   More FDA Info for this Device
510(K) Number	K100139
Device Name	Respirator,Surgical
Applicant	SAFELIFE CORP. 12250 EL CAMINO REAL SUITE 350 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	ALBERT REGO 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	01/19/2010
Decision Date	05/04/2010
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