K132767 is an FDA 510(k) clearance for the MEDLINE SHARPS CONTAINER. 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 February 3, 2014, 152 days after receiving the submission on September 4, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K132767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2013 |
| Decision Date | February 03, 2014 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MMK — Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |