The following data is part of a premarket notification filed by Optimaxx Intl. with the FDA for Norma Kamlali/alfred Sung/roots Of Canada/steel Maxx Sunglass.
| Device ID | K973016 |
| 510k Number | K973016 |
| Device Name: | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | OPTIMAXX INTL. 10 VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Maureen Marcason |
| Correspondent | Maureen Marcason OPTIMAXX INTL. 10 VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1997-09-17 |