510(k) K083387 ยท HKI Camera, Ophthalmic, Ac-Powered
MODIFICATION TO KOWA NONMYD ALPHA-DIII
| Applicant | Kowa Co. , Ltd., Chuo-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Nov 17, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083387
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.