The following data is part of a premarket notification filed by Rainbow Merchandise, Inc. with the FDA for Rewinner Ent Co. Ltd. Non-prescription Sunglasses.
| Device ID | K940830 |
| 510k Number | K940830 |
| Device Name: | REWINNER ENT CO. LTD. NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | RAINBOW MERCHANDISE, INC. 4121 S. ALAMEDA ST. Los Angeles, CA 90058 |
| Contact | Kitty Chu |
| Correspondent | Kitty Chu RAINBOW MERCHANDISE, INC. 4121 S. ALAMEDA ST. Los Angeles, CA 90058 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-04-11 |