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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
510(k) Number K153633
Device Name Endoform Reconstructive Template
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
2 Kingsford Smith Place, Airport Oaks
Auckland,  NZ 2022
Applicant Contact Yasmin Rai
ICON plc
62 Forest Street
Marlborough,  MA  01752
Correspondent Contact Gordon MacFarlane
Regulation Number878.3300
Classification Product Code
Date Received12/18/2015
Decision Date 03/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls