The following data is part of a premarket notification filed by Leibinger & Fischer Ltd. with the FDA for Neuro N 50 Lesion Generator.
| Device ID | K896450 |
| 510k Number | K896450 |
| Device Name: | NEURO N 50 LESION GENERATOR |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | LEIBINGER & FISCHER LTD. 4500 TRAMMELL CROW CENTER 2001 ROSS AVENUE Dallas, TX 75201 |
| Contact | Paul Stewart |
| Correspondent | Paul Stewart LEIBINGER & FISCHER LTD. 4500 TRAMMELL CROW CENTER 2001 ROSS AVENUE Dallas, TX 75201 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-09 |
| Decision Date | 1991-03-19 |