K874504 is an FDA 510(k) clearance for the MICRO-AIRE PULSE LAVAGE. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on December 29, 1987, 57 days after receiving the submission on November 2, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K874504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1987 |
| Decision Date | December 29, 1987 |
| Days to Decision | 57 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 |