The following data is part of a premarket notification filed by Blublocker Corp. with the FDA for Colorvision Sunglasses.
Device ID | K900381 |
510k Number | K900381 |
Device Name: | COLORVISION SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | BLUBLOCKER CORP. 3100 DUNDEE RD SUITE 802 Northbrook, IL 60062 |
Contact | Joseph Sugarman |
Correspondent | Joseph Sugarman BLUBLOCKER CORP. 3100 DUNDEE RD SUITE 802 Northbrook, IL 60062 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-25 |
Decision Date | 1990-02-13 |