The following data is part of a premarket notification filed by Viveve Inc. with the FDA for Viveve System.
| Device ID | K162547 |
| 510k Number | K162547 |
| Device Name: | Viveve System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Viveve Inc. 150 Commercial Street Sunnyvale, CA 94086 |
| Contact | Jim Talbot |
| Correspondent | Jim Talbot Viveve Inc. 150 Commercial Street Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2016-10-06 |
| Summary: | summary |