The following data is part of a premarket notification filed by American Medical Optics with the FDA for Medical Optics Phacoemulsification Kit.
| Device ID | K844150 |
| 510k Number | K844150 |
| Device Name: | MEDICAL OPTICS PHACOEMULSIFICATION KIT |
| Classification | Unit, Phacofragmentation |
| Applicant | AMERICAN MEDICAL OPTICS 1402 EAST ALTON AVE. Irvine, CA 92714 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky AMERICAN MEDICAL OPTICS 1402 EAST ALTON AVE. Irvine, CA 92714 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-24 |
| Decision Date | 1984-12-11 |