AURAGEN CORTICAL SURFACE ELECTRODES— 510(k) K082250
Substantially EquivalentIntegra Neurosciences
FDA 510(k) clearance K082250 for AURAGEN CORTICAL SURFACE ELECTRODES, Substantially Equivalent on 2008-10-10. Applicant: Integra Neurosciences. Device class: 2.
Clearance details
- Applicant
- Integra Neurosciences
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Planisboro, NJ, US
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More clearances from Integra Neurosciences
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- K021989 — SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
- K022554 — MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.