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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
Predetermined Change
Control Plan Authorized		 No
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