510(k) K972836 ยท LTZ Condom With Nonoxynol-9
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
| Applicant | G. Premjee (Usa), Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Oct 22, 1997 |
| Received | Jul 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972836
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.