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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 K153632
Device Name Endoform Reconstructive Template
Applicant
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
2 Kingsford Smith Place, Airport Oaks
Auckland,  NZ 2022
Applicant Contact Yasmin Rai
Correspondent
Icon Plc
62 Forest St.
Marlborough,  MA  01752
Correspondent Contact GORDON MACFARLANE
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
FTM  
Date Received12/18/2015
Decision Date 06/16/2016
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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