The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Model 329t Programmable, Bipolar Cardi.
| Device ID | K832893 |
| 510k Number | K832893 |
| Device Name: | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. 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 | 1983-08-26 |
| Decision Date | 1983-10-04 |