AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
FDA 510(k) clearance K010008 · decided 2001-07-16
Clearance details
- K-number
- K010008
- Device name
- AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
- Applicant
- Micronet Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-02
- Decision date
- 2001-07-16
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- GZB
- Device class
- 2
- Regulation number
- 882.5880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- White Bear Lake,, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.