VEINWAVE, TC3000
FDA 510(k) clearance K083352 · decided 2009-06-12
Clearance details
- K-number
- K083352
- Device name
- VEINWAVE, TC3000
- Applicant
- Newlands Clinical Trials, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-13
- Decision date
- 2009-06-12
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- ONQ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Claremont, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| MED RF 4000 (K210077) | F Care Systems USA, LLC | 2021-12-17 |
| EVRF SYSTEM (K130283) | F Care Systems NV | 2013-03-07 |
| VEIN-GOGH INSTRUMENT (K112334) | Refine USA, LLC | 2012-05-08 |
Recalls involving this device
No recalls on record reference this clearance.