K910728 is an FDA 510(k) clearance for the CLEANFLOW SYSTEM. This device is classified as a Evacuator, Gastro-urology (Class II - Special Controls, product code KQT).
Submitted by Mitron Technologies, Inc. (Dayville, US). The FDA issued a Cleared decision on April 1, 1991, 40 days after receiving the submission on February 20, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4370.
| 510(k) Number | K910728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1991 |
| Decision Date | April 01, 1991 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KQT — Evacuator, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4370 |