510(k) K010371 ยท HIS Condom
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
| Applicant | Suretex, Ltd., Dothan AL, US |
| Decision | Substantially Equivalent, Apr 27, 2001 |
| Received | Feb 7, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010371
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.