The following data is part of a premarket notification filed by Valleylab with the FDA for Cool-tip Rf Ablation System.
| Device ID | K042216 |
| 510k Number | K042216 |
| Device Name: | COOL-TIP RF ABLATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg 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 | 2004-08-16 |
| Decision Date | 2004-11-12 |
| Summary: | summary |