The following data is part of a premarket notification filed by Eurotrends Eyewear, Inc. with the FDA for Chronoswiss,baleno,bonia,otmar Alt, New Jersey.
| Device ID | K961746 |
| 510k Number | K961746 |
| Device Name: | CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EUROTRENDS EYEWEAR, INC. 1702 OLD MINTERS CHAPEL RD. SUITE 102 Grapevine, TX 76051 |
| Contact | Denise Kalis |
| Correspondent | Denise Kalis EUROTRENDS EYEWEAR, INC. 1702 OLD MINTERS CHAPEL RD. SUITE 102 Grapevine, TX 76051 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-06 |
| Decision Date | 1996-05-16 |