510(k) K911844 ยท HIG Insufflator, Hysteroscopic
HYSTEROFLATOR 1500
| Applicant | F.M. Wiest USA, Inc., Oradel NJ, US |
| Decision | Substantially Equivalent, Nov 21, 1991 |
| Received | Apr 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911844
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.