The following data is part of a premarket notification filed by Riviera Optical Co., Ltd. with the FDA for Riviera Sunglass4es.
| Device ID | K972194 |
| 510k Number | K972194 |
| Device Name: | RIVIERA SUNGLASS4ES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | RIVIERA OPTICAL CO., LTD. 1314 NORTH HUNTER ST. SUITE 202 Baltimore, MD 21202 |
| Contact | James Logan |
| Correspondent | James Logan RIVIERA OPTICAL CO., LTD. 1314 NORTH HUNTER ST. SUITE 202 Baltimore, MD 21202 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-10 |
| Decision Date | 1997-06-24 |