The following data is part of a premarket notification filed by Newlands Clinical Trials Ltd with the FDA for Veinwave, Tc3000.
| Device ID | K083352 |
| 510k Number | K083352 |
| Device Name: | VEINWAVE, TC3000 |
| Classification | Electrosurgical Coagulation For Aesthetic |
| Applicant | NEWLANDS CLINICAL TRIALS LTD 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose NEWLANDS CLINICAL TRIALS LTD 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | ONQ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2009-06-12 |
| Summary: | summary |