510(k) K981621 ยท LTZ Condom With Nonoxynol-9
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
| Applicant | Suretex Prophylactics (India) , Ltd., Bangalore, Karnataka, IN |
| Decision | Substantially Equivalent, Jun 19, 1998 |
| Received | May 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.