510(k) K910597 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2
| Applicant | Radix Group Intl., Columbus OH, US |
| Decision | Substantially Equivalent, Apr 26, 1991 |
| Received | Feb 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910597
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.