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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
510(k) Number K083823
Device Name SECURIAN TISSUE REINFORCEMENT MATRIX
Applicant
Xylos Corporation
838 Town Center Dr.
Langhorne,  PA  19047
Applicant Contact JOYCE ELKINS
Correspondent
Xylos Corporation
838 Town Center Dr.
Langhorne,  PA  19047
Correspondent Contact JOYCE ELKINS
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/22/2008
Decision Date 03/18/2009
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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