510(k) K961048 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
OLYMPUS MH-246R BALLOON SHEATH
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Sep 16, 1996 |
| Received | Mar 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961048
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.