The following data is part of a premarket notification filed by Tpl-cordis, Inc. with the FDA for Model 255a Programmer Iii, W/software Revi. 4004.
| Device ID | K882429 |
| 510k Number | K882429 |
| Device Name: | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 |
| Classification | Programmer, Pacemaker |
| Applicant | TPL-CORDIS, INC. 7400 SO. TUCSON WAY Englewood, CO 80112 |
| Contact | Duane A Schultz |
| Correspondent | Duane A Schultz TPL-CORDIS, INC. 7400 SO. TUCSON WAY Englewood, CO 80112 |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-07-22 |