Submission Details
| 510(k) Number | K983750 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
Nov 1998
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K983750 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Deroyal Industries, Inc. (Knoxville, 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 review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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