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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
Model MAG1-1515, MAG1-1520, MAG1-2020,MAG1-2030
Device Name MEDLINX SURGICAL MESH
Applicant
MEDLINX ACALA PTE LTD
3502 dundee drive
chevy chase,  MD  20815
Contact stephen p rhodes
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/20/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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