510(k) K981343 ยท LKY Device, External Penile Rigidity
ERCO-RIBBON
| Applicant | Ercons, Inc., New York NY, US |
| Decision | Substantially Equivalent, Nov 24, 1998 |
| Received | Apr 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981343
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.