The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Elcam Antimicrobial Closed Stopcocks (dss And Tss).
| Device ID | K082106 |
| 510k Number | K082106 |
| Device Name: | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) |
| Classification | Stopcock, I.v. Set |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Contact | Tali Hazan |
| Correspondent | Tali Hazan 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-25 |
| Decision Date | 2008-10-02 |
| Summary: | summary |