SKINTACT
FDA 510(k) clearance K140340 · decided 2014-05-21
Clearance details
- K-number
- K140340
- Device name
- SKINTACT
- Applicant
- Leonhard Lang GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-02-11
- Decision date
- 2014-05-21
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.