510(k) K962915 ยท LKY Device, External Penile Rigidity
ACTIS (VENOUS FLOW CONTROLLER)
| Applicant | Vivus, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Dec 10, 1996 |
| Received | Jul 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962915
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.