The following data is part of a premarket notification filed by Ultimate Concepts, Inc. with the FDA for Eassun Hi-tech Optics.
| Device ID | K943202 |
| 510k Number | K943202 |
| Device Name: | EASSUN HI-TECH OPTICS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ULTIMATE CONCEPTS, INC. 2761 OCEAN CLUB BLVD. #106 Hollywood, FL 33019 |
| Contact | Andrea S Cross |
| Correspondent | Andrea S Cross ULTIMATE CONCEPTS, INC. 2761 OCEAN CLUB BLVD. #106 Hollywood, FL 33019 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1994-07-27 |