510(k) K970465 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
BOUSER'S URINAL
| Applicant | General Polymers, Great Neck NY, US |
| Decision | Substantially Equivalent, Dec 18, 1997 |
| Received | Feb 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970465
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.