LEVEEN SUPERSLIM NEEDLE ELECTRODE
FDA 510(k) clearance K113090 · decided 2012-03-15
Clearance details
- K-number
- K113090
- Device name
- LEVEEN SUPERSLIM NEEDLE ELECTRODE
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-10-19
- Decision date
- 2012-03-15
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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