510(k) K012664 ยท HIS Condom
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
| Applicant | Innolatex Sdn. Bhd, Shah Alam,Selangor Darul Ehsan, MY |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012664
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.