510(k) K901318 ยท LKY Device, External Penile Rigidity
STAYEREC SYSTEM(TM)
| Applicant | Osbon Medical Systems, Ltd., Augusta GA, US |
| Decision | Substantially Equivalent, May 4, 1990 |
| Received | Mar 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901318
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.