The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Disposable Rf Cannulae (sc-c, Rfk-db, Rfk-ds).
| Device ID | K980430 |
| 510k Number | K980430 |
| Device Name: | RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Jeff Mannion |
| Correspondent | Jeff Mannion RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-04 |
| Decision Date | 1998-03-16 |
| Summary: | summary |