The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Ful-vue Aspheric Cataract Lens.
Device ID | K790251 |
510k Number | K790251 |
Device Name: | FUL-VUE ASPHERIC CATARACT LENS |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQG |
CFR Regulation Number | 886.5844 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-06 |
Decision Date | 1979-02-26 |