510(k) K971327 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
UNIKA
| Applicant | Eyewear Partners Co., Miami FL, US |
| Decision | Substantially Equivalent, May 9, 1997 |
| Received | Apr 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971327
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.