FDA 510(k), K053358, DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
FDA 510(k), K053358, DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
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510(K) Number: K053358
Device Name: DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
Manufacturer: AD-TECH MEDICAL INSTRUMENT CORP.
Device Classification Name: electrode, depth
Regulation Number: 882.1330
Classification Product Code: GZL
Date Received: 12/02/2005
Decision Date: 05/25/2006
Regulation Medical Specialty: Neurology
Device Name: DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
Manufacturer: AD-TECH MEDICAL INSTRUMENT CORP.
Device Classification Name: electrode, depth
Regulation Number: 882.1330
Classification Product Code: GZL
Date Received: 12/02/2005
Decision Date: 05/25/2006
Regulation Medical Specialty: Neurology
- 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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