510(k) K981591 ยท FAD Stent, Ureteral
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
| Applicant | International Regulatory Consultants, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 9, 1998 |
| Received | May 4, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K981591
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.