510(k) K903715 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
CONDOM SEAL
| Applicant | Mark Sullivan, M.D., P.C., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Jan 23, 1991 |
| Received | Aug 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903715
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.