BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013— 510(k) K101128

Name: FDA 510(k) clearance K101128
Creator: U.S. Food and Drug Administration
Published: 2011-05-26

Substantially Equivalent

Filligent Limited

FDA 510(k) clearance K101128 for BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013, Substantially Equivalent on 2011-05-26. Applicant: Filligent Limited. Device class: 2.

Clearance details

Applicant: Filligent Limited
Product code: Code OUK
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2010-04-22
Decision date: 2011-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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