The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Closed Swabable Stopcock And Minimal Residual Volume Luer-activated Swabable-stopcock.
| Device ID | K060231 |
| 510k Number | K060231 |
| Device Name: | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK |
| 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 | 2006-01-30 |
| Decision Date | 2006-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290102590015 | K060231 | 000 |