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FDA 510(k), K173582, ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
FDA 510(k), K173582, ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
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510(K) Number: K173582
Device Name: ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
Manufacturer: ThermiGen, L.L.C
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/20/2017
Decision Date: 01/17/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
Manufacturer: ThermiGen, L.L.C
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/20/2017
Decision Date: 01/17/2018
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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