The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Atrial Endocardial Electrode Lead Of J.
| Device ID | K811593 |
| 510k Number | K811593 |
| Device Name: | ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J |
| Classification | Permanent Pacemaker Electrode |
| Applicant | TELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-08 |
| Decision Date | 1981-10-13 |