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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 K172636
Device Name VitaMESH Macroporous PP Surgical Mesh
Applicant
Proxy Biomedical , Ltd.
Coilleach, Spiddal
Galway,  IE
Applicant Contact Adrienne Tierney
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/01/2017
Decision Date 04/30/2018
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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