The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Cool-tip Rf System.
| Device ID | K984552 |
| 510k Number | K984552 |
| Device Name: | COOL-TIP RF SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Jeffrey R Mannion |
| Correspondent | Jeffrey R Mannion RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-22 |
| Decision Date | 1999-03-05 |