510(k) K110852 ยท HIG Insufflator, Hysteroscopic
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Jul 19, 2011 |
| Received | Mar 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110852
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.