K203305 is an FDA 510(k) clearance for the Tiger Reusable Sharps Container. 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 August 6, 2021, 270 days after receiving the submission on November 9, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K203305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2020 |
| Decision Date | August 06, 2021 |
| Days to Decision | 270 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 |