510(k) K980917 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
| Applicant | Fortune Medical Instrument Corp., Irvine CA, US |
| Decision | Substantially Equivalent, May 27, 1998 |
| Received | Mar 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980917
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.