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FDA 510(k), K983007, NEUROTUBE
FDA 510(k), K983007, NEUROTUBE
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510(K) Number: K983007
Device Name: NEUROTUBE
Manufacturer: NEUROREGEN, L.L.C.
Device Classification Name: Cuff, Nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 08/28/1998
Decision Date: 03/22/1999
Regulation Medical Specialty: Neurology
Device Name: NEUROTUBE
Manufacturer: NEUROREGEN, L.L.C.
Device Classification Name: Cuff, Nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 08/28/1998
Decision Date: 03/22/1999
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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