The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Keates Irrigation/aspiration/vitreous.
| Device ID | K834437 |
| 510k Number | K834437 |
| Device Name: | KEATES IRRIGATION/ASPIRATION/VITREOUS |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | FRIGITRONICS OF CONNECTICUT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-03-30 |