FDA 510(k), K171626, truFreeze System
FDA 510(k), K171626, truFreeze System
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510(K) Number: K171626
Device Name: truFreeze System
Manufacturer: CSA Medical, Inc.
Device Classification Name: Unit, Cryosurgical, Accessories
Regulation Number: 878.4350
Classification Product Code: GEH
Date Received: 06/02/2017
Decision Date: 08/30/2017
Regulation Medical Specialty: General & Plastic Surgery
Device Name: truFreeze System
Manufacturer: CSA Medical, Inc.
Device Classification Name: Unit, Cryosurgical, Accessories
Regulation Number: 878.4350
Classification Product Code: GEH
Date Received: 06/02/2017
Decision Date: 08/30/2017
Regulation Medical Specialty: General & Plastic Surgery
- 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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