510(k) K914407 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)
| Applicant | Promedex, Inc., Fort Woth TX, US |
| Decision | Substantially Equivalent, Dec 31, 1991 |
| Received | Oct 2, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914407
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.