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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 K112499
Device Name BIOMERIX COMPOSITE SURGICAL MESH
Applicant
BIOMERIX CORPORATION
47757 FREMONT BLVD
FREMONT,  CA  94538
Applicant Contact CHRISTINA L KICHULA
Correspondent
BIOMERIX CORPORATION
47757 FREMONT BLVD
FREMONT,  CA  94538
Correspondent Contact CHRISTINA L KICHULA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/30/2011
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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