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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name N95 Respirator With Antimicrobial/Antiviral Agent
510(k) Number K122702
Device Name BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
Applicant
Filligent Limited
7th Fllor, 69 Jervois St.,
Sheung Wan
Hong Kong,  CN HK
Applicant Contact KAI DEUSCH
Correspondent
Filligent Limited
7th Fllor, 69 Jervois St.,
Sheung Wan
Hong Kong,  CN HK
Correspondent Contact KAI DEUSCH
Regulation Number878.4040
Classification Product Code
ONT  
Date Received09/04/2012
Decision Date 03/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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