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FDA 510(k), K130919, SENSUS
FDA 510(k), K130919, SENSUS
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510(K) Number: K130919
Device Name: SENSUS
Manufacturer: RAINER MAAS
Device Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation Number: GZJ
Classification Product Code: KXA
Date Received: 04/03/2013
Decision Date: 07/02/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: SENSUS
Manufacturer: RAINER MAAS
Device Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation Number: GZJ
Classification Product Code: KXA
Date Received: 04/03/2013
Decision Date: 07/02/2013
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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