510(k) K161195 ยท HIS Condom
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
| Applicant | M3 Global Enterprises, LLC, Beavercreek OH, US |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Apr 27, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K161195
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.