The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Lead Models Mum 1260, Mum 1290.
| Device ID | K790386 |
| 510k Number | K790386 |
| Device Name: | LEAD MODELS MUM 1260, MUM 1290 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | ELA MEDICAL, INC. 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 | 1979-02-26 |
| Decision Date | 1979-04-03 |