N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695— 510(k) K092824

Name: FDA 510(k) clearance K092824
Creator: U.S. Food and Drug Administration
Published: 2009-10-21

Substantially Equivalent

Alpha Protech, Inc.

FDA 510(k) clearance K092824 for N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695, Substantially Equivalent on 2009-10-21. Applicant: Alpha Protech, Inc.. Device class: 2.

Clearance details

Applicant: Alpha Protech, Inc.
Product code: Code MSH
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2009-09-14
Decision date: 2009-10-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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