510(k) K181387 ยท MIB Elastomer, Silicone Block
Pre-Formed Penile Silicone Block
| Applicant | International Medical Devices, Inc., Beverly Hills CA, US |
| Decision | Substantially Equivalent, Jan 23, 2019 |
| Received | May 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181387
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.