510(k) K001859 ยท LKY Device, External Penile Rigidity
PENILE CONSTRICTOR RING
| Applicant | Basic Solutions, LLC, Santa Monica CA, US |
| Decision | Substantially Equivalent, Jan 11, 2001 |
| Received | Jun 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001859
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.