The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Implantable Electrode Leads 033-400,402 And 436.
| Device ID | K884278 |
| 510k Number | K884278 |
| Device Name: | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | TELECTRONICS, INC. 7400 TUSCON WAY Englewood, CO 80112 |
| Contact | Duane Schultz |
| Correspondent | Duane Schultz TELECTRONICS, INC. 7400 TUSCON WAY Englewood, CO 80112 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-12 |
| Decision Date | 1988-12-15 |