TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
FDA 510(k) clearance K062946 · decided 2007-02-15
Clearance details
- K-number
- K062946
- Device name
- TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
- Applicant
- Top Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-28
- Decision date
- 2007-02-15
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Dunwoody, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.