The following data is part of a premarket notification filed by Medwaves Incorporated with the FDA for Medwaves Microwave Coagulation/ablation System.
| Device ID | K070356 |
| 510k Number | K070356 |
| Device Name: | MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MEDWAVES INCORPORATED 16760 WEST BERNARDO DRIVE San Diego, CA 92127 |
| Contact | Ted Ormsby |
| Correspondent | Ted Ormsby MEDWAVES INCORPORATED 16760 WEST BERNARDO DRIVE San Diego, CA 92127 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-12-18 |
| Summary: | summary |