The following data is part of a premarket notification filed by American Medical Optics with the FDA for Irrigation Aspiration Kit.
Device ID | K833405 |
510k Number | K833405 |
Device Name: | IRRIGATION ASPIRATION KIT |
Classification | Unit, Phacofragmentation |
Applicant | AMERICAN MEDICAL OPTICS 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 | 1983-09-30 |
Decision Date | 1984-01-06 |