510(k) K132042 ยท HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
| Applicant | X6d, Ltd., Zur- Moshe, IL |
| Decision | Substantially Equivalent, Apr 28, 2014 |
| Received | Jul 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132042
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.