510(k) K973016 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS
| Applicant | Optimaxx Intl., Rockleigh NJ, US |
| Decision | Substantially Equivalent, Sep 17, 1997 |
| Received | Aug 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973016
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.