510(k) K923136 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
MALE EXTERNAL CATHETER
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, Dec 3, 1992 |
| Received | Jun 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923136
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.