510(k) K182438 ยท MOL Condom, Synthetic
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
| Applicant | Sxwell USA, LLC, Iselin NJ, US |
| Decision | Substantially Equivalent, Dec 6, 2018 |
| Received | Sep 7, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K182438
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.