The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Safeport Manifold (tm) (or Stopcock).
| Device ID | K111016 |
| 510k Number | K111016 |
| Device Name: | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) |
| Classification | Set, Administration, Intravascular |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Contact | Natasha Evronyan |
| Correspondent | Natasha Evronyan ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-12 |
| Decision Date | 2011-06-09 |
| Summary: | summary |