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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 K063154
Device Name FACIAL RECONSTRUCTIVE MESH (FRM)
Applicant
Evera Medical, Inc.
353 Vintage Park Dr.
Suite F
Foster City,  CA  94404
Applicant Contact RANDY KESTEN
Correspondent
Evera Medical, Inc.
353 Vintage Park Dr.
Suite F
Foster City,  CA  94404
Correspondent Contact RANDY KESTEN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/16/2006
Decision Date 07/10/2007
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
Predetermined Change
Control Plan Authorized		 No
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