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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
Model PROFESSIONAL BF-200-3013AN
Device Name BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
Original Applicant
FILLIGENT LIMITED
7th fllor, 69 jervois street,
sheung wan
hong kong,  CH hk
Original Contact kai deusch
Regulation Number878.4040
Classification Product Code
ONT  
Date Received09/05/2012
Decision Date 03/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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