510(k) K853790 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
| Applicant | Rocky Mountain Medical Corp., Greenwood Village CO, US |
| Decision | Substantially Equivalent, Oct 4, 1985 |
| Received | Sep 10, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853790
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.