510(k) K200073 ยท MIB Elastomer, Silicone Block
AugMENTA Penile Implant
| Applicant | Augmenta, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Sep 30, 2022 |
| Received | Jan 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200073
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.