The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Disposable High Pressure Stopcock/manifold Model Hp Stopcock, Mp Stopcock, Hp Manifold, Php Manifold.
| Device ID | K123084 |
| 510k Number | K123084 |
| Device Name: | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD |
| Classification | Stopcock, I.v. Set |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Contact | Aharon Cohen |
| Correspondent | Aharon Cohen ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-05-23 |
| Summary: | summary |