510(k) K132597 ยท HIS Condom
BLACK COLOURED CONDOM
| Applicant | Karex Industries Sdn. Bhd., Pontian Kecil, Jalan Johor, MY |
| Decision | Substantially Equivalent, Nov 25, 2013 |
| Received | Aug 19, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132597
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.