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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 K162461
Device Name Endoform Plastics and Reconstructive Matrix
Applicant
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
2 KINGSFORD SMITH PLACE, AIRPORT OAKS
AUCKLAND,  NZ 2022
Applicant Contact Yasmin Rai
Correspondent
ICON PLC
62 FOREST STREET, SUITE 300
MARLBOROUGH,  MA  01752
Correspondent Contact Gordon MacFarlane
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/02/2016
Decision Date 12/20/2016
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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