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FDA 510(k), K160754, Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
FDA 510(k), K160754, Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
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510(K) Number: K160754
Device Name: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
Manufacturer: VENCLOSE, INC.
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 03/18/2016
Decision Date: 09/09/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
Manufacturer: VENCLOSE, INC.
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 03/18/2016
Decision Date: 09/09/2016
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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