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FDA 510(k), K212835, AquaBeam Robotic System
FDA 510(k), K212835, AquaBeam Robotic System
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510(K) Number: K212835
Device Name: AquaBeam Robotic System
Manufacturer: PROCEPT BioRobotics Corporation
Device Classification Name: Fluid Jet Removal System
Regulation Number: 876.4350
Classification Product Code: PZP
Date Received: 09/07/2021
Decision Date: 10/06/2021
Regulation Medical Specialty: General & Plastic Surgery
Device Name: AquaBeam Robotic System
Manufacturer: PROCEPT BioRobotics Corporation
Device Classification Name: Fluid Jet Removal System
Regulation Number: 876.4350
Classification Product Code: PZP
Date Received: 09/07/2021
Decision Date: 10/06/2021
Regulation Medical Specialty: General & Plastic Surgery
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- 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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