The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Postoperative Uv Glasses (plano/aphakic).
Device ID | K802651 |
510k Number | K802651 |
Device Name: | POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
Product Code | HQG |
CFR Regulation Number | 886.5844 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-24 |
Decision Date | 1980-12-17 |