FDA 510(k), K190180, CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k), K190180, CUSA Clarity Ultrasonic Surgical Aspirator System
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510(K) Number: K190180
Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System
Manufacturer: Alexandra Wells
Device Classification Name: Instrument, Ultrasonic Surgical
Regulation Number: LFL
Classification Product Code: 02/01/2019
Date Received: 04/01/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System
Manufacturer: Alexandra Wells
Device Classification Name: Instrument, Ultrasonic Surgical
Regulation Number: LFL
Classification Product Code: 02/01/2019
Date Received: 04/01/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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