510(k) K012964 ยท HIS Condom
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
| Applicant | Innolatex Sdn. Bhd, Shah Alam, Selangor D.E., MY |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Sep 4, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012964
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.