The following data is part of a premarket notification filed by Covidien Lp, Formerly Know As Valleylab, A Divison with the FDA for Valleylab Microwave Ablation Generator.
| Device ID | K072687 |
| 510k Number | K072687 |
| Device Name: | VALLEYLAB MICROWAVE ABLATION GENERATOR |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Philip E Ake |
| Correspondent | Philip E Ake COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-24 |
| Decision Date | 2008-11-25 |
| Summary: | summary |