510(k) K163107 ยท HIS Condom
Lifestyles Zero Lubricated Latex Male Condom
| Applicant | Ansell Healthcare Products, LLC, Iselin NJ, US |
| Decision | Substantially Equivalent, Jan 23, 2017 |
| Received | Nov 7, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K163107
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.