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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 K120844
Device Name MEDLINX SURGICAL MESH
Original Applicant
MEDLINX ACALA PTE LTD
3502 dundee drive
chevy chase,  MD  20815
Original Contact stephen p rhodes
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/20/2012
Decision Date 12/13/2012
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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