The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Lead Introducer Sets-eb-s8 & Eb-s12.
| Device ID | K831751 |
| 510k Number | K831751 |
| Device Name: | LEAD INTRODUCER SETS-EB-S8 & EB-S12 |
| Classification | Introducer, Catheter |
| Applicant | Oscor Inc. 3816 DeSoto Blvd. Palm Harbor, FL 34683 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-01 |
| Decision Date | 1983-10-20 |