The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for 3.2mm Unipolar & Bipolar Lead Connectors (vs-1).
| Device ID | K862966 |
| 510k Number | K862966 |
| Device Name: | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Contact | James A Cormack |
| Correspondent | James A Cormack OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-06 |
| Decision Date | 1986-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836559002857 | K862966 | 000 |