510(k) K943161 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
ORVIS DRIVING GLASSES
| Applicant | The Orvis Co., Inc., Manchester VT, US |
| Decision | Substantially Equivalent, Aug 4, 1994 |
| Received | Jul 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943161
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.