The following data is part of a premarket notification filed by Rainbow Optics, Inc. with the FDA for Sunglasses.
| Device ID | K934277 |
| 510k Number | K934277 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | RAINBOW OPTICS, INC. 2 NORHTEAST 40TH ST. Miami, FL 33137 -3510 |
| Contact | Perry Popkin |
| Correspondent | Perry Popkin RAINBOW OPTICS, INC. 2 NORHTEAST 40TH ST. Miami, FL 33137 -3510 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1994-02-09 |