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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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$89.00 USD
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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: KXA
Date Received: 10/02/2020
Decision Date: 11/24/2020
Decision: 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: KXA
Date Received: 10/02/2020
Decision Date: 11/24/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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