BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR— 510(k) K122702

Name: FDA 510(k) clearance K122702
Creator: U.S. Food and Drug Administration
Published: 2013-03-18

Substantially Equivalent

Filligent Limited

FDA 510(k) clearance K122702 for BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR, Substantially Equivalent on 2013-03-18. Applicant: Filligent Limited. Device class: 2.

Clearance details

Applicant: Filligent Limited
Product code: Code ONT
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2012-09-04
Decision date: 2013-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.