510(k) K043150 ยท HNO Keratome, Ac-Powered
AMADEUS II EPIKERATOME
| Applicant | Sis Ltd., Surgical Instrument Systems, Littleton CO, US |
| Decision | Substantially Equivalent, Jan 31, 2005 |
| Received | Nov 15, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043150
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.