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FDA 510(k), K960728, ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
FDA 510(k), K960728, ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
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510(K) Number: K960728
Device Name: ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
Manufacturer: NEUROMED, INC.
Device Classification Name: stimulator, spinal-cord, implanted (pain relief)
Regulation Number: 882.5880
Classification Product Code: GZB
Date Received: 02/22/1996
Decision Date: 05/22/1996
Regulation Medical Specialty: Neurology
Device Name: ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
Manufacturer: NEUROMED, INC.
Device Classification Name: stimulator, spinal-cord, implanted (pain relief)
Regulation Number: 882.5880
Classification Product Code: GZB
Date Received: 02/22/1996
Decision Date: 05/22/1996
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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