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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 K161550
Device Name DynaMesh-VENTRAL
Applicant
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT
PRAGER RING 70
AACHEN,  DE D-52070
Applicant Contact STEFAN SCHNEEMELCHER
Correspondent
MEDDIQUEST LIMITED
HERLINGTON HOUSE
ORTON MALBORNE
PETERBOROUGH,  GB PE2 5XS
Correspondent Contact NEIL R. ARMSTRONG
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/03/2016
Decision Date 12/22/2016
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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