510(k) K994118 ยท HIS Condom
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
| Applicant | Guilin Latex Factory, San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 14, 2000 |
| Received | Dec 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2007 | Global Protection Corp. Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA Terminated |
HIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.