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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K223373
Device Name Enivo™
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 Number878.4780
Classification Product Code
BTA  
Date Received11/04/2022
Decision Date 04/07/2023
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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