510(k) K971576 ยท LKY Device, External Penile Rigidity
REJOYN PENILE SUPPORT SYSTEM
| Applicant | American Medtech, Washington DC, US |
| Decision | Substantially Equivalent, Oct 16, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971576
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.