The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Cooper Vision I/a System Iii Model 1500.
| Device ID | K822220 |
| 510k Number | K822220 |
| Device Name: | COOPER VISION I/A SYSTEM III MODEL 1500 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | COOPERVISION, 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 | 1982-07-26 |
| Decision Date | 1982-10-06 |