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FDA 510(k), K200774, CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k), K200774, CUSA Clarity Ultrasonic Surgical Aspirator System
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$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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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