The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Keates Irrigation/aspiration/vitreous Cutter 5000.
| Device ID | K853308 |
| 510k Number | K853308 |
| Device Name: | KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | FRIGITRONICS OF CONNECTICUT, INC. 770 RIVER RD. P.O. BOX 855 Shelton, CT 06484 |
| Contact | Cliff F Potocky |
| Correspondent | Cliff F Potocky FRIGITRONICS OF CONNECTICUT, INC. 770 RIVER RD. P.O. BOX 855 Shelton, CT 06484 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-07 |
| Decision Date | 1985-10-04 |