The following data is part of a premarket notification filed by Refine Usa, Llc with the FDA for Vein-gogh Instrument.
| Device ID | K112334 |
| 510k Number | K112334 |
| Device Name: | VEIN-GOGH INSTRUMENT |
| Classification | Electrosurgical Coagulation For Aesthetic |
| Applicant | REFINE USA, LLC 340 3RD AVENUE SOUTH SUITE C Jacksonville Beach, FL 32250 |
| Contact | Brian Smith |
| Correspondent | Brian Smith REFINE USA, LLC 340 3RD AVENUE SOUTH SUITE C Jacksonville Beach, FL 32250 |
| Product Code | ONQ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 86573000021011 | K112334 | 000 |