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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 K081882
Device Name MODIFICATION TO XYLOS SURGICAL MESH
Applicant
Xylos Corporation
838 Town Center Dr.
Langhorne,  PA  19047
Applicant Contact GERRY ANN OSTER
Correspondent
Xylos Corporation
838 Town Center Dr.
Langhorne,  PA  19047
Correspondent Contact GERRY ANN OSTER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received07/02/2008
Decision Date 07/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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