The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Elcam Stopcocks And Manifolds.
| Device ID | K190489 |
| 510k Number | K190489 |
| Device Name: | Elcam Stopcocks And Manifolds |
| Classification | Stopcock, I.v. Set |
| Applicant | Elcam Medical ACAL Kibbutz Baram Kibbutz Baram, IL 1386000 |
| Contact | Avital Levertov |
| Correspondent | Avital Levertov Elcam Medical ACAL Kibbutz Baram Kibbutz Baram, IL 1386000 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2019-04-23 |