The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Implantable Unipolar Cardiac Pulse Gen.
| Device ID | K833428 |
| 510k Number | K833428 |
| Device Name: | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | TELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-04 |
| Decision Date | 1984-02-10 |