510(k) K971977 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Aug 12, 1997 |
| Received | May 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971977
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.