510(k) K971132 ยท HIS Condom
ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
| Applicant | G. Premjee (Usa), Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Sep 3, 1997 |
| Received | Mar 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971132
| 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.