K844411 is an FDA 510(k) clearance for the SCRUB MATE DRY STERILE SCRUB BRUSH. This device is classified as a Brush, Scrub, Operating-room (Class I - General Controls, product code GEC).
Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on December 17, 1984, 33 days after receiving the submission on November 14, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K844411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1984 |
| Decision Date | December 17, 1984 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEC — Brush, Scrub, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |