THE WESTERN CORTICAL ELECTRODE ARRAY
FDA 510(k) clearance K923330 · decided 1993-11-09
Clearance details
- K-number
- K923330
- Device name
- THE WESTERN CORTICAL ELECTRODE ARRAY
- Applicant
- University Hospital (London) Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-07
- Decision date
- 1993-11-09
- Days to decision
- 490 days
- Clearance type
- Traditional
- Product code
- GYC
- Device class
- 2
- Regulation number
- 882.1310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- London Ontario N6a 5n6, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.