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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
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