The following data is part of a premarket notification filed by Viveve Inc. with the FDA for Viveve Rf System, Secure.
| Device ID | K180584 |
| 510k Number | K180584 |
| Device Name: | Viveve RF System, Secure |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Viveve Inc. 345 Inverness Dr S, Building B, Suite 250 Englewood, CO 80112 |
| Contact | Suzon Lommel |
| Correspondent | Suzon Lommel Viveve Inc. 345 Inverness Dr S, Building B, Suite 250 Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-06 |
| Summary: | summary |