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FDA 510(k), K151296, Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
FDA 510(k), K151296, Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
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510(K) Number: K151296
Device Name: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
Manufacturer: BIOS S.R.L.
Device Classification Name: massager, vacuum, radio frequency induced heat
Regulation Number: 878.4400
Classification Product Code: PBX
Date Received: 05/15/2015
Decision Date: 11/19/2015
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
Manufacturer: BIOS S.R.L.
Device Classification Name: massager, vacuum, radio frequency induced heat
Regulation Number: 878.4400
Classification Product Code: PBX
Date Received: 05/15/2015
Decision Date: 11/19/2015
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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