The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Oscor Medical Implantable Pacing Lead, Retractable.
| Device ID | K850623 |
| 510k Number | K850623 |
| Device Name: | OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. KAYE, SCHOLER, FIERMAN, HAYS & 1575 EYE STREET NW Washington, DC 20005 |
| Contact | Allen M Fox |
| Correspondent | Allen M Fox OSCOR MEDICAL CORP. KAYE, SCHOLER, FIERMAN, HAYS & 1575 EYE STREET NW Washington, DC 20005 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-04-19 |