510(k) K971443 ยท LKY Device, External Penile Rigidity
RAPPORT V.T.D.
| Applicant | Owen Mumford USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Sep 26, 1997 |
| Received | Apr 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971443
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.