The following data is part of a premarket notification filed by Valleylab with the FDA for Cool-tip Rf Generator, Cool-tip Rf System Accessories.
| Device ID | K052796 |
| 510k Number | K052796 |
| Device Name: | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Robert C Moore |
| Correspondent | Robert C Moore VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-02-03 |
| Summary: | summary |