The following data is part of a premarket notification filed by Blublocker Corp. with the FDA for Sunblocker Sunglasses.
Device ID | K950807 |
510k Number | K950807 |
Device Name: | SUNBLOCKER SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | BLUBLOCKER CORP. 3350 PALMS CENTER DR. Las Vegas, NV 89103 |
Contact | Mary Stanke |
Correspondent | Mary Stanke BLUBLOCKER CORP. 3350 PALMS CENTER DR. Las Vegas, NV 89103 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-22 |
Decision Date | 1995-05-24 |