510(k) K946231 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
EYE COOLER
| Applicant | Direct Import Marketing Co., Mansfield TX, US |
| Decision | Substantially Equivalent, Jan 17, 1995 |
| Received | Dec 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946231
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.