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FDA 510(k), K123516, CRYO-TOUCH IV
FDA 510(k), K123516, CRYO-TOUCH IV
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510(K) Number: K123516
Device Name: CRYO-TOUCH IV
Manufacturer: TRACEY HENRY
Device Classification Name: Device, Surgical, Cryogenic
Regulation Number: GXH
Classification Product Code: 11/14/2012
Date Received: 01/10/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: CRYO-TOUCH IV
Manufacturer: TRACEY HENRY
Device Classification Name: Device, Surgical, Cryogenic
Regulation Number: GXH
Classification Product Code: 11/14/2012
Date Received: 01/10/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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