510(k) K000408 ยท HIS Condom
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
| Applicant | Suretex Prophylactics , Ltd., Dothan AL, US |
| Decision | Substantially Equivalent, Apr 19, 2000 |
| Received | Feb 8, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K000408
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2013 | Ansell Healthcare Products LLC Lifestyles Pleasure Collection
30 Premium Lubricated Condoms
Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin.
UPC 0-70907-02625-0. Terminated |
HIS | None listed |
| Dec 31, 2002 | Ansell Healthcare Inc LifeStyles Assorted Colors Condoms with Spermicide Terminated |
LTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.