The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Versatome I.
| Device ID | K820008 |
| 510k Number | K820008 |
| Device Name: | VERSATOME I |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ALPHAMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-04 |
| Decision Date | 1982-02-22 |