510(k) K012653 ยท HIS Condom
MALE LATEX CONDOM
| Applicant | Qingdao Shuang Die Latex Production Co.,Ltd, Durham NC, US |
| Decision | Substantially Equivalent, Sep 21, 2001 |
| Received | Aug 13, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012653
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.