The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Flexi-q Dv And Dvr Auto-injectors.
| Device ID | K111467 |
| 510k Number | K111467 |
| Device Name: | FLEXI-Q DV AND DVR AUTO-INJECTORS |
| Classification | Introducer, Syringe Needle |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Contact | Shay Shaham |
| Correspondent | Shay Shaham ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-26 |
| Decision Date | 2012-02-09 |
| Summary: | summary |