510(k) K000124 ยท LKY Device, External Penile Rigidity
SENSATION -VACUUM ASSIST DEVICES
| Applicant | Prosurg, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jul 10, 2000 |
| Received | Jan 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000124
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.