The following data is part of a premarket notification filed by Floater Eyewear, Inc. with the FDA for Floater Sunglasses.
Device ID | K931431 |
510k Number | K931431 |
Device Name: | FLOATER SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | FLOATER EYEWEAR, INC. 6924 PLAINFIELD RD. Cincinnati, OH 45236 |
Contact | Clifford A York |
Correspondent | Clifford A York FLOATER EYEWEAR, INC. 6924 PLAINFIELD RD. Cincinnati, OH 45236 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-22 |
Decision Date | 1993-10-01 |