510(k) K153483 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Balloon controller PB-30
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Dec 15, 2015 |
| Received | Dec 3, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153483
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.