The following data is part of a premarket notification filed by William C. Nealon with the FDA for Telectronics #030-253 Bifurcated.
| Device ID | K831303 |
| 510k Number | K831303 |
| Device Name: | TELECTRONICS #030-253 BIFURCATED |
| Classification | Permanent Pacemaker Electrode |
| Applicant | WILLIAM C. NEALON 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-21 |
| Decision Date | 1983-05-25 |