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FDA 510(k), K212871, Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
FDA 510(k), K212871, Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
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510(K) Number: K212871
Device Name: Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Manufacturer: Galvanize Therapeutics, Inc.
Device Classification Name: Low Energy Direct Current Thermal Ablation System
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 09/09/2021
Decision Date: 06/17/2022
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Manufacturer: Galvanize Therapeutics, Inc.
Device Classification Name: Low Energy Direct Current Thermal Ablation System
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 09/09/2021
Decision Date: 06/17/2022
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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