FDA 510(k), K203024, C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
FDA 510(k), K203024, C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
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510(K) Number: K203024
Device Name: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
Manufacturer: Gurvinder Singh Nanda
Device Classification Name: Unit, Cryosurgical, Accessories
Regulation Number: GEH
Classification Product Code: 10/02/2020
Date Received: 11/24/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
Manufacturer: Gurvinder Singh Nanda
Device Classification Name: Unit, Cryosurgical, Accessories
Regulation Number: GEH
Classification Product Code: 10/02/2020
Date Received: 11/24/2020
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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