K111577 is an FDA 510(k) clearance for the MEDLINE VIAL DECANTER. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 8, 2011, 93 days after receiving the submission on June 7, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K111577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2011 |
| Decision Date | September 08, 2011 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |