510(k) K181673 ยท FAE Prosthesis, Penile
Rigi10 Malleable Penile Prosthesis
| Applicant | Rigicon, Inc., Hauppauge NY, US |
| Decision | Substantially Equivalent, Apr 15, 2019 |
| Received | Jun 25, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K181673
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.