The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Models Ul-804 And Bl-801 Unipolar Leads.
| Device ID | K791552 |
| 510k Number | K791552 |
| Device Name: | MODELS UL-804 AND BL-801 UNIPOLAR LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-14 |
| Decision Date | 1979-09-04 |