510(k) K090814 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Apr 20, 2009 |
| Received | Mar 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090814
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.