The following data is part of a premarket notification filed by E-tay Industrial Co. Ltd. with the FDA for Disco Sunglasses/headband Sunglasses.
Device ID | K832564 |
510k Number | K832564 |
Device Name: | DISCO SUNGLASSES/HEADBAND SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | E-TAY INDUSTRIAL CO. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-02 |
Decision Date | 1983-09-12 |