510(k) K981506 ยท LKY Device, External Penile Rigidity
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
| Applicant | Repro-Med Systems, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jun 25, 1998 |
| Received | Apr 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981506
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.