SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150— 510(k) K100139

Name: FDA 510(k) clearance K100139
Creator: U.S. Food and Drug Administration
Published: 2010-05-04

Substantially Equivalent

Safelife Corp.

FDA 510(k) clearance K100139 for SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150, Substantially Equivalent on 2010-05-04. Applicant: Safelife Corp.. Device class: 2.

Clearance details

Applicant: Safelife Corp.
Product code: Code MSH
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2010-01-19
Decision date: 2010-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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