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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 K111584
Device Name XYLOS MACRO-POROUS SURGICAL MESH
Applicant
XYLOS CORPORATION
838 TOWN CENTER DR.
LANGHORNE,  PA  19047
Applicant Contact GONZALO C SERAFICA
Correspondent
XYLOS CORPORATION
838 TOWN CENTER DR.
LANGHORNE,  PA  19047
Correspondent Contact GONZALO C SERAFICA
Regulation Number878.3300
Classification Product Code
FTM  
Date Received06/07/2011
Decision Date 08/25/2011
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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