FDA 510(k), K200774, CUSA Clarity Ultrasonic Surgical Aspirator System

FDA 510(k), K200774, CUSA Clarity Ultrasonic Surgical Aspirator System

Regular price $89.00 USD
Regular price Sale price $89.00 USD
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510(K) Number: K200774
Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System
Manufacturer: Alexandra Wells
Device Classification Name: Instrument, Ultrasonic Surgical
Regulation Number: LFL
Classification Product Code: KXA
Date Received: 03/25/2020
Decision Date: 06/23/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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