The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Elcam Stopcocks And Manifolds.
| Device ID | K141254 |
| 510k Number | K141254 |
| Device Name: | ELCAM STOPCOCKS AND MANIFOLDS |
| Classification | Stopcock, I.v. Set |
| Applicant | ELCAM MEDICAL ACAL KIBBUTZ BARAM Mp Merom Hagalil, IL 1386000 |
| Contact | Natasha Branzburg |
| Correspondent | Natasha Branzburg ELCAM MEDICAL ACAL KIBBUTZ BARAM Mp Merom Hagalil, 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 | 2014-05-14 |
| Decision Date | 2014-07-30 |
| Summary: | summary |