The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Vascular Products Implantable Pacing.
Device ID | K830950 |
510k Number | K830950 |
Device Name: | VASCULAR PRODUCTS IMPLANTABLE PACING |
Classification | Permanent Pacemaker Electrode |
Applicant | Oscor Inc. 3816 DeSoto Blvd. Palm Harbor, FL 34683 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-25 |
Decision Date | 1983-04-18 |