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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 K073287
Device Name PREVADH MESH
Applicant
Sofradim Production
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact SHARON ALEXANDER
Correspondent
Sofradim Production
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact SHARON ALEXANDER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/21/2007
Decision Date 03/13/2008
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 Yes
Predetermined Change
Control Plan Authorized		 No
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