The following data is part of a premarket notification filed by Radiotherapeutics Corp. with the FDA for Leveen Electrode.
| Device ID | K012315 |
| 510k Number | K012315 |
| Device Name: | LEVEEN ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIOTHERAPEUTICS CORP. 1308 BORREGAS AVE.SUITE 200 Sunnyvale, CA 94089 |
| Contact | Kirsten Valley |
| Correspondent | Kirsten Valley RADIOTHERAPEUTICS CORP. 1308 BORREGAS AVE.SUITE 200 Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-10-11 |
| Summary: | summary |