510(k) K946004 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
FI, GORDY TOY, WELLJOY AND OTHERS
| Applicant | Fundamental Industrial Co., Ltd., Kowloon, Hong Kong, HK |
| Decision | Substantially Equivalent, Jan 31, 1995 |
| Received | Dec 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946004
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.