| K-number | K053535 |
| Device name | VIVAWAVE MICROWAVE ABLATION SYSTEM |
| Applicant | Valleylab |
| Product code | NEY |
| Device class | Class II |
| Decision date | Apr 27, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov