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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 K023237
Device Name XYLOS SURGICAL MESH
Applicant
Xylos Corporation
815 Connecticut Ave., NW
Suite 800
Washington,  DC  20006
Applicant Contact Patsy Trisler
Correspondent
Xylos Corporation
815 Connecticut Ave., NW
Suite 800
Washington,  DC  20006
Correspondent Contact Patsy Trisler
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/27/2002
Decision Date 03/18/2003
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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