510(k) K970944 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
BARAKKA, INFERNO, STERLING, AND/OR ONE
| Applicant | Sentinal Importing Corp., North Vancouver, B.C., CA |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Mar 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970944
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.