510(k) K003115 ยท LKY Device, External Penile Rigidity
ACTIS ADJUSTABLE CONSTRICTION LOOP
| Applicant | Vivus, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 19, 2000 |
| Received | Oct 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003115
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.