510(k) K981011 ยท LKY Device, External Penile Rigidity
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
| Applicant | Pos-T-Vac, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Aug 28, 1998 |
| Received | Mar 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981011
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.