ACTIPROTECT UF N95 RESPIRATOR— 510(k) K093161

Name: FDA 510(k) clearance K093161
Creator: U.S. Food and Drug Administration
Published: 2010-05-10

Substantially Equivalent

Glaxosmithkline Consumer Healthcare

FDA 510(k) clearance K093161 for ACTIPROTECT UF N95 RESPIRATOR, Substantially Equivalent on 2010-05-10. Applicant: Glaxosmithkline Consumer Healthcare. Device class: 2.

Clearance details

Applicant: Glaxosmithkline Consumer Healthcare
Product code: Code ONT
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2009-10-06
Decision date: 2010-05-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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