510(k) K980948 ยท LKY Device, External Penile Rigidity
VED VALU- VACUUM ERECTION DEVICE
| Applicant | Mission Pharmacal Comp, New York NY, US |
| Decision | Substantially Equivalent, Jun 25, 1998 |
| Received | Mar 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980948
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.