510(k) K913294 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
| Applicant | Surgitek Medical Engineering Corp., Racine WI, US |
| Decision | Substantially Equivalent, Oct 4, 1991 |
| Received | Jul 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913294
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.