The following data is part of a premarket notification filed by European & Foreign Imports, Inc. with the FDA for Non-prescription Sunglasses.
| Device ID | K925596 |
| 510k Number | K925596 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EUROPEAN & FOREIGN IMPORTS, INC. 1372 E. 15TH ST. Los Angeles, CA 90021 |
| Contact | Maurice Castiel |
| Correspondent | Maurice Castiel EUROPEAN & FOREIGN IMPORTS, INC. 1372 E. 15TH ST. Los Angeles, CA 90021 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1994-07-12 |