510(k) K012639 ยท LKY Device, External Penile Rigidity
SE-300 VACUUM THERAPY SYSTEM
| Applicant | Vts, Inc., Newkirk OK, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012639
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.