510(k) K972100 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
| Applicant | Advanced Care Medical Products, Novato CA, US |
| Decision | Substantially Equivalent, Jul 31, 1997 |
| Received | Jun 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972100
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.