K211464 is an FDA 510(k) clearance for the Nitta M&T Safety Box. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Nitta M&T (Thailand) Co., Ltd. (Khlong Luang, TH). The FDA issued a Cleared decision on September 14, 2021, 126 days after receiving the submission on May 11, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K211464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2021 |
| Decision Date | September 14, 2021 |
| Days to Decision | 126 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 |