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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 K183398
Device Name Endoform Restella
Applicant
Aroa Biosurgery , Ltd.
2 Kingsford Smith Place
Airport Oaks,  NZ 2022
Applicant Contact Tina O’Brien
Correspondent
Aroa Biosurgery , Ltd.
2 Kingsford Smith Place
Airport Oaks,  NZ 2022
Correspondent Contact Tina O’Brien
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
FTL  
Date Received12/07/2018
Decision Date 04/11/2019
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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