510(k) K943131 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
ORVIS POLARIZED BI-FOCALS
| Applicant | The Orvis Co., Inc., Manchester VT, US |
| Decision | Substantially Equivalent, Aug 2, 1994 |
| Received | Jun 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943131
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.