The following data is part of a premarket notification filed by Gentex Corporation with the FDA for Rx Lens Series.
Device ID | K772024 |
510k Number | K772024 |
Device Name: | RX LENS SERIES |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | GENTEX CORPORATION 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 | 1977-10-26 |
Decision Date | 1977-11-09 |