The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Model Jy Pacemaker Lead - Various.
| Device ID | K823889 |
| 510k Number | K823889 |
| Device Name: | MODEL JY PACEMAKER LEAD - VARIOUS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | Oscor Inc. 3816 DeSoto Blvd. Palm Harbor, FL 34683 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-27 |
| Decision Date | 1983-04-30 |