The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Alphamedix I/a Hand-piece, 500-001.
| Device ID | K830812 |
| 510k Number | K830812 |
| Device Name: | ALPHAMEDIX I/A HAND-PIECE, 500-001 |
| Classification | Unit, Phacofragmentation |
| Applicant | ALPHAMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-15 |
| Decision Date | 1983-06-08 |