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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 K131530
Device Name DYNAMESH -CICAT
Applicant
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
HERLINGTON HOUSE, ORTON MALBORNE
PETERBOROUGH, CAMBS.,  GB PE2 5XS
Applicant Contact NEIL R ARMSTRONG
Correspondent
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
HERLINGTON HOUSE, ORTON MALBORNE
PETERBOROUGH, CAMBS.,  GB PE2 5XS
Correspondent Contact NEIL R ARMSTRONG
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/28/2013
Decision Date 10/23/2013
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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