510(k) K983320 ยท HIS Condom
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
| Applicant | Suretex Prophylactics (India) , Ltd., Bangalore, Karnataka, IN |
| Decision | Substantially Equivalent, Dec 11, 1998 |
| Received | Sep 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983320
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.