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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K112567
Device Name BIOMERIX ASSURE
Original Applicant
BIOMERIX CORPORATION
47757 fremont blvd
fremont,  CA  94538
Original Contact christina l kichula
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/02/2011
Decision Date 12/23/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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