K943626 is an FDA 510(k) clearance for the ISOLYSER SHARPS MANAGEMENT SYSTEM SMS. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Thantex Specialties, Inc. (Norcross, US). The FDA issued a Cleared decision on June 16, 1995, 325 days after receiving the submission on July 26, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K943626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1994 |
| Decision Date | June 16, 1995 |
| Days to Decision | 325 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |