The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Temp. Pacing Leads W/depth Markings Ta-1 And Tb-1.
| Device ID | K884866 |
| 510k Number | K884866 |
| Device Name: | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | De Graad |
| Correspondent | De Graad OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 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 | 1988-11-21 |
| Decision Date | 1989-03-22 |