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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K100139
Device Name SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
Applicant
Safelife Corp.
12250 El Camino Real
Suite 350
San Diego,  CA  92130
Applicant Contact ALBERT REGO
Correspondent
Safelife Corp.
12250 El Camino Real
Suite 350
San Diego,  CA  92130
Correspondent Contact ALBERT REGO
Regulation Number878.4040
Classification Product Code
MSH  
Date Received01/19/2010
Decision Date 05/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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