K820661 is an FDA 510(k) clearance for the MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Micro-Aire Surgical Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on April 21, 1982, 42 days after receiving the submission on March 10, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K820661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1982 |
| Decision Date | April 21, 1982 |
| Days to Decision | 42 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 |