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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 K023328
Device Name REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
Applicant
CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES
11800 BALTIMORE AVE.NUE
SUITE 105
BELTSVILLE,  MD  20705
Applicant Contact MELISSA MAHALL
Correspondent
CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES
11800 BALTIMORE AVE.NUE
SUITE 105
BELTSVILLE,  MD  20705
Correspondent Contact MELISSA MAHALL
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/04/2002
Decision Date 12/12/2002
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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