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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 K093799
Device Name TORNIER SURGICAL MESH
Applicant
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Applicant Contact HOWARD L SCHRAYER
Correspondent
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Correspondent Contact HOWARD L SCHRAYER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/10/2009
Decision Date 04/22/2010
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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