The following data is part of a premarket notification filed by Mid Laboratories, Inc. with the FDA for Aspirator/irrigator Or I/a Unit.
| Device ID | K820889 |
| 510k Number | K820889 |
| Device Name: | ASPIRATOR/IRRIGATOR OR I/A UNIT |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | MID LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-30 |
| Decision Date | 1982-05-05 |