The following data is part of a premarket notification filed by Alpha Omega Engineering Ltd. with the FDA for Sterile Leadconfirm.
| Device ID | K191739 |
| 510k Number | K191739 |
| Device Name: | Sterile LeadConfirm |
| Classification | Electrode, Depth |
| Applicant | Alpha Omega Engineering Ltd. Nazareth Industrial Park, Mount Precipice, St. 2015 Nazareth, IL 1612102 |
| Contact | Maysana Mousa |
| Correspondent | Maysana Mousa Alpha Omega Engineering Ltd. Nazareth Industrial Park, Mount Precipice, St. 2015 Nazareth, IL 1612102 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2020-01-02 |