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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 K080442
Device Name SERISCAFFOLD SURGICAL MESH
Applicant
Serica Technologies, Inc.
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Applicant Contact CONNIE H GARRISON
Correspondent
Serica Technologies, Inc.
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Correspondent Contact CONNIE H GARRISON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/19/2008
Decision Date 11/13/2008
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 No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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