The following data is part of a premarket notification filed by Amsure Sports, Inc. with the FDA for Venneto.
| Device ID | K974045 |
| 510k Number | K974045 |
| Device Name: | VENNETO |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | AMSURE SPORTS, INC. 1818 NAIO STREET, SUITE B Honolulu, HI 96817 |
| Contact | Wendy W.c. Siu |
| Correspondent | Wendy W.c. Siu AMSURE SPORTS, INC. 1818 NAIO STREET, SUITE B Honolulu, HI 96817 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-24 |
| Decision Date | 1997-11-20 |