The following data is part of a premarket notification filed by Palm Optical Co., Inc. with the FDA for Eyeglass Frames And Sunglasses.
| Device ID | K926065 |
| 510k Number | K926065 |
| Device Name: | EYEGLASS FRAMES AND SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | PALM OPTICAL CO., INC. 20157 N.E. 16TH PL. North Miami Beach, FL 33179 |
| Contact | Joanne Besner |
| Correspondent | Joanne Besner PALM OPTICAL CO., INC. 20157 N.E. 16TH PL. North Miami Beach, FL 33179 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-08-05 |