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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: KXA
Date Received: 11/14/2012
Decision Date: 01/10/2013
Decision: 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: KXA
Date Received: 11/14/2012
Decision Date: 01/10/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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