K922781 is an FDA 510(k) clearance for the FLOW CONROL VALVE. This device is classified as a Cpb Check Valve, Retrograde Flow, In-line (Class II - Special Controls, product code MJJ).
Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on March 8, 1993, 272 days after receiving the submission on June 9, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K922781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1992 |
| Decision Date | March 08, 1993 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJJ — Cpb Check Valve, Retrograde Flow, In-line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |