The following data is part of a premarket notification filed by Techna Vision with the FDA for Techna Vision Casting Resin.
Device ID | K862578 |
510k Number | K862578 |
Device Name: | TECHNA VISION CASTING RESIN |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | TECHNA VISION 11489 WOODSIDE AVE. Santee, CA 92071 |
Contact | James T Kelley |
Correspondent | James T Kelley TECHNA VISION 11489 WOODSIDE AVE. Santee, CA 92071 |
Product Code | HQG |
CFR Regulation Number | 886.5844 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-07 |
Decision Date | 1986-07-23 |