The following data is part of a premarket notification filed by Floats, Inc. with the FDA for Floats Sunglasses.
Device ID | K932151 |
510k Number | K932151 |
Device Name: | FLOATS SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | FLOATS, INC. 1515 CLEVELAND RD. Miami Beach, FL 33141 |
Contact | Rafael Egozi |
Correspondent | Rafael Egozi FLOATS, INC. 1515 CLEVELAND RD. Miami Beach, FL 33141 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-04 |
Decision Date | 1994-01-03 |