510(k) K934197 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
OPTIKOS SHAMI, INC. SUNGLASSES
| Applicant | Optikos Shami, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 25, 1994 |
| Received | Aug 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934197
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.