K143693 is an FDA 510(k) clearance for the MEDLINE SHARPS CONTAINERS. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 6, 2015, 317 days after receiving the submission on December 24, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K143693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2014 |
| Decision Date | November 06, 2015 |
| Days to Decision | 317 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMK — Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |