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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 K090880
Device Name XYLOS POROUS SURGICAL MESH
Original Applicant
XYLOS CORPORATION
838 town center dr.
langhorne,  PA  19047
Original Contact joyce elkins
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/31/2009
Decision Date 05/27/2009
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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