510(k) K970078 ยท HIG Insufflator, Hysteroscopic
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
| Applicant | Davol Inc., Sub. C. R. Bard, Inc., Canston RI, US |
| Decision | Substantially Equivalent, Dec 11, 1997 |
| Received | Jan 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970078
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.