510(k) K113061 ยท HIS Condom
LARGE/EXTRA LAGRE CONDOM
| Applicant | Karex Industries Sdn. Bhd., Johor Darul Takzim, MY |
| Decision | Substantially Equivalent, Dec 7, 2011 |
| Received | Oct 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113061
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.