510(k) K922197 ยท HIG Insufflator, Hysteroscopic
INSUFFLATOR TUBING KIT
| Applicant | O.R. Concepts, Inc., Roanoke TX, US |
| Decision | Substantially Equivalent, Sep 24, 1993 |
| Received | May 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922197
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.