FDA 510(k), K202166, Senhance Surgical System
FDA 510(k), K202166, Senhance Surgical System
Device Name: Senhance Surgical System
Manufacturer: Kaitlyn Alexander
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: KXA
Date Received: 08/03/2020
Decision Date: 03/02/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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