The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Keates I/a System Frigitronics 4000.
| Device ID | K822599 |
| 510k Number | K822599 |
| Device Name: | KEATES I/A SYSTEM FRIGITRONICS 4000 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | FRIGITRONICS OF CONNECTICUT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HKP |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-27 |
| Decision Date | 1982-10-06 |