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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 K073579
Device Name DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
Applicant
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
BUSINESS & TECHNOLOGY CENTER/
BESSEMER DRIVE
STEVENAGE,  GB SG1 2DX
Applicant Contact NEIL R ARMSTRONG
Correspondent
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
BUSINESS & TECHNOLOGY CENTER/
BESSEMER DRIVE
STEVENAGE,  GB SG1 2DX
Correspondent Contact NEIL R ARMSTRONG
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/20/2007
Decision Date 08/18/2008
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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