FDA 510(k), K150089, NanoKnife System
FDA 510(k), K150089, NanoKnife System
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510(K) Number: K150089
Device Name: NanoKnife System
Manufacturer: ANGIODYNAMICS, INC.
Device Classification Name: low energy direct current thermal ablation system
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 01/16/2015
Decision Date: 06/18/2015
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NanoKnife System
Manufacturer: ANGIODYNAMICS, INC.
Device Classification Name: low energy direct current thermal ablation system
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 01/16/2015
Decision Date: 06/18/2015
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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