FDA 510(k), K182720, Freedom Spinal Cord Stimulator (SCS) System
FDA 510(k), K182720, Freedom Spinal Cord Stimulator (SCS) System
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510(K) Number: K182720
Device Name: Freedom Spinal Cord Stimulator (SCS) System
Manufacturer: Stimwave Technologies Incorporated
Device Classification Name: stimulator, spinal-cord, implanted (pain relief)
Regulation Number: 882.5880
Classification Product Code: GZB
Date Received: 09/28/2018
Decision Date: 03/29/2019
Regulation Medical Specialty: Neurology
Device Name: Freedom Spinal Cord Stimulator (SCS) System
Manufacturer: Stimwave Technologies Incorporated
Device Classification Name: stimulator, spinal-cord, implanted (pain relief)
Regulation Number: 882.5880
Classification Product Code: GZB
Date Received: 09/28/2018
Decision Date: 03/29/2019
Regulation Medical Specialty: Neurology
- 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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