The following data is part of a premarket notification filed by American Medical Optics with the FDA for American Medical Optics I/a Kit- Irrig.
Device ID | K842197 |
510k Number | K842197 |
Device Name: | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | AMERICAN MEDICAL OPTICS 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 | 1984-06-04 |
Decision Date | 1984-10-01 |