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FDA 510(k), K202781, Neuspera Neurostimulation System (NNS)
FDA 510(k), K202781, Neuspera Neurostimulation System (NNS)
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510(K) Number: K202781
Device Name: Neuspera Neurostimulation System (NNS)
Manufacturer: Alexander Yeh
Device Classification Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation Number: GZF
Classification Product Code: KXA
Date Received: 09/22/2020
Decision Date: 08/27/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Neuspera Neurostimulation System (NNS)
Manufacturer: Alexander Yeh
Device Classification Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation Number: GZF
Classification Product Code: KXA
Date Received: 09/22/2020
Decision Date: 08/27/2021
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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