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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
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