510(k) K012672 ยท LKY Device, External Penile Rigidity
BOSS-2000-2 VACUUM ERECTION DEVICE
| Applicant | Pos-T-Vac, Inc., Dodge City KS, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012672
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.