The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Temp. Cardiac Pacing Wire Tme 60/61/65.
| Device ID | K831695 |
| 510k Number | K831695 |
| Device Name: | TEMP. CARDIAC PACING WIRE TME 60/61/65 |
| 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 | 1983-05-25 |
| Decision Date | 1983-10-20 |