510(k) K970895 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
CUSTOM OPTICAL SUNGLASS FRAMES
| Applicant | Custom Optical Frames, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Mar 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970895
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.