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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgical mask with antimicrobial/antiviral agent
510(k) Number K101128
FOIA Releasable 510(k) K101128
Device Name BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
Applicant
FILLIGENT LIMITED
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN,  TX  78701
Applicant Contact IAN GORDON
Correspondent
FILLIGENT LIMITED
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN,  TX  78701
Correspondent Contact IAN GORDON
Regulation Number878.4040
Classification Product Code
OUK  
Date Received04/22/2010
Decision Date 05/26/2011
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
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