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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
FOIA Releasable 510(k) K053656
Device Name TYRX ANTIMICROBIAL MESH
Applicant
Tyrx Pharma, Inc.
1 Deer Park Dr. Suite G
Monmouth Junction,  NJ  08852
Applicant Contact MASON W DIAMOND
Correspondent
Tyrx Pharma, Inc.
1 Deer Park Dr. Suite G
Monmouth Junction,  NJ  08852
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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