The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Y-click Connector.
| Device ID | K060759 |
| 510k Number | K060759 |
| Device Name: | Y-CLICK CONNECTOR |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | ELCAM MEDICAL ACAL KIBUTZ BARAM D.n. Merom Hagalil, IL 13860 |
| Contact | Tali Hazan |
| Correspondent | Tali Hazan ELCAM MEDICAL ACAL KIBUTZ BARAM D.n. Merom Hagalil, IL 13860 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-06-29 |
| Summary: | summary |