510(k) K891125 ยท LKY Device, External Penile Rigidity
CONSTRICTOR RING FOR PENILE ERECTION
| Applicant | Performance, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Apr 27, 1989 |
| Received | Mar 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891125
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.