K190240 is an FDA 510(k) clearance for the Tiger Sharps Containers. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by International Marketing Specialists, Inc. (Somerset, US). The FDA issued a Cleared decision on May 31, 2019, 114 days after receiving the submission on February 6, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K190240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2019 |
| Decision Date | May 31, 2019 |
| Days to Decision | 114 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 |