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FDA 510(k), K082474, PMT SUBDURAL CORTICAL ELECTRODES
FDA 510(k), K082474, PMT SUBDURAL CORTICAL ELECTRODES
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510(K) Number: K082474
Device Name: PMT SUBDURAL CORTICAL ELECTRODES
Manufacturer: ERIC CAILLE
Device Classification Name: Electrode, Cortical
Regulation Number: GYC
Classification Product Code: 08/28/2008
Date Received: 05/08/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: PMT SUBDURAL CORTICAL ELECTRODES
Manufacturer: ERIC CAILLE
Device Classification Name: Electrode, Cortical
Regulation Number: GYC
Classification Product Code: 08/28/2008
Date Received: 05/08/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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