K082106 is an FDA 510(k) clearance for the ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS). This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on October 2, 2008, 69 days after receiving the submission on July 25, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K082106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2008 |
| Decision Date | October 02, 2008 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |