510(k) K961078 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
AUTOMATED VITRECTOMY DEVICE
| Applicant | Promex, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 14, 1996 |
| Received | Mar 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961078
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.