510(k) K891290 ยท HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
| Applicant | Cook Ob/Gyn, Spencer IN, US |
| Decision | Substantially Equivalent, May 23, 1989 |
| Received | Mar 10, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891290
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.