The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Model Py...u Unipolar & Bipolar Pacing Lead.
| Device ID | K870034 |
| 510k Number | K870034 |
| Device Name: | MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor, FL 33563 |
| Contact | Brian K Cornish |
| Correspondent | Brian K Cornish 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 | 1987-01-05 |
| Decision Date | 1987-03-03 |