510(k) K881135 ยท HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
COOL EYE(TM) EYE PROTECTOR
| Applicant | Cool Eyes, Inc., Harrow, Ontario, CA |
| Decision | Substantially Equivalent, Jul 8, 1988 |
| Received | Mar 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881135
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.