K874022 is an FDA 510(k) clearance for the PHARMASEAL WOUND IRRIGATION DEVICE. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on December 30, 1987, 89 days after receiving the submission on October 2, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K874022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1987 |
| Decision Date | December 30, 1987 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |