FDA 510(k), K053363, DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
FDA 510(k), K053363, DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
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510(K) Number: K053363
Device Name: DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
Manufacturer: Gary Syring
Device Classification Name: Electrode, Cortical
Regulation Number: GYC
Classification Product Code: 12/02/2005
Date Received: 05/30/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
Manufacturer: Gary Syring
Device Classification Name: Electrode, Cortical
Regulation Number: GYC
Classification Product Code: 12/02/2005
Date Received: 05/30/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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