510(k) K802082 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
POLARIS SPECTACLE FRAMES & LENSES
| Applicant | Polaris Optics USA, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 13, 1981 |
| Received | Aug 28, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802082
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.