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510(k) K223373

Enivo™ by Aroa Biosurgery , Ltd. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2023
Date Received
November 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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