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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, polymeric
510(k) Number K053656
Device Name TYRX ANTIMICROBIAL MESH
Original Applicant
TYRX PHARMA INC
1 deer park dr
suite g
monmouth junction,  NJ  08852
Original Contact mason w diamond
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/30/2005
Decision Date 07/14/2006
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 Yes
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