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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
Applicant
Medlinx Acala Pte, Ltd.
3502 Dundee Dr.
Chevy Chase,  MD  20815
Applicant Contact STEPHEN P RHODES
Correspondent
Medlinx Acala Pte, Ltd.
3502 Dundee Dr.
Chevy Chase,  MD  20815
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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