The following data is part of a premarket notification filed by Robinson-houchin, Inc. with the FDA for Blended Bifocal.
Device ID | K802749 |
510k Number | K802749 |
Device Name: | BLENDED BIFOCAL |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | ROBINSON-HOUCHIN, INC. 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 | 1980-11-03 |
Decision Date | 1980-12-17 |