The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Temp. Pacing Lead, Bipolar #th60, 90/110.
| Device ID | K830772 |
| 510k Number | K830772 |
| Device Name: | TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | Oscor Inc. 3816 DeSoto Blvd. Palm Harbor, FL 34683 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-11 |
| Decision Date | 1983-04-18 |