510(k) K971992 ยท FHA Clamp, Penile
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
| Applicant | Uromed Corp., Needham MA, US |
| Decision | Substantially Equivalent, Aug 1, 1997 |
| Received | May 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971992
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.