The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Disposable Mini & Maxi Lavag.
| Device ID | K820661 |
| 510k Number | K820661 |
| Device Name: | MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG |
| Classification | Lavage, Jet |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-10 |
| Decision Date | 1982-04-21 |