K983750 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on November 30, 1998, 38 days after receiving the submission on October 23, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K983750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1998 |
| Decision Date | November 30, 1998 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |