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FDA 510(k), K133453, IOVERA
FDA 510(k), K133453, IOVERA
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510(K) Number: K133453
Device Name: IOVERA
Manufacturer: BIJESH CHANDRAN
Device Classification Name: Device, Surgical, Cryogenic
Regulation Number: GXH
Classification Product Code: KXA
Date Received: 11/12/2013
Decision Date: 03/24/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: IOVERA
Manufacturer: BIJESH CHANDRAN
Device Classification Name: Device, Surgical, Cryogenic
Regulation Number: GXH
Classification Product Code: KXA
Date Received: 11/12/2013
Decision Date: 03/24/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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