510(k) K982725 ยท ITX Transducer, Ultrasonic, Diagnostic
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Oct 23, 1998 |
| Received | Aug 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982725
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.