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FDA 510(k), K163118, FLEX Microwave Ablation System and Accessories
FDA 510(k), K163118, FLEX Microwave Ablation System and Accessories
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510(K) Number: K163118
Device Name: FLEX Microwave Ablation System and Accessories
Manufacturer: DAN KOSEDNAR
Device Classification Name: System, Ablation, Microwave And Accessories
Regulation Number: NEY
Classification Product Code: 11/08/2016
Date Received: 03/09/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: FLEX Microwave Ablation System and Accessories
Manufacturer: DAN KOSEDNAR
Device Classification Name: System, Ablation, Microwave And Accessories
Regulation Number: NEY
Classification Product Code: 11/08/2016
Date Received: 03/09/2017
Decision Date: Substantially Equivalent (SESE)
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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