The following data is part of a premarket notification filed by Radiotherapeutics Corp. with the FDA for Leveen Needle Electrode(tm).
| Device ID | K950347 |
| 510k Number | K950347 |
| Device Name: | LEVEEN NEEDLE ELECTRODE(TM) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIOTHERAPEUTICS CORP. 2685 MARINE WAY, SUITE 1408 Mountain View, CA 94043 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols RADIOTHERAPEUTICS CORP. 2685 MARINE WAY, SUITE 1408 Mountain View, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-02-23 |