K760494 is an FDA 510(k) clearance for the BASIN, ROUND WASH. This device is classified as a Basin, Emesis (Class I - General Controls, product code FNY).
Submitted by Landmark Plastics (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976, 81 days after receiving the submission on August 23, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6730.
| 510(k) Number | K760494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1976 |
| Decision Date | November 12, 1976 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FNY — Basin, Emesis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6730 |