510(k) K983797 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
| Applicant | Dutch Ophthalmic USA, Inc., Kingston NH, US |
| Decision | Substantially Equivalent, Mar 3, 1999 |
| Received | Oct 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983797
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.