510(k) K082258 ยท FXX Mask, Surgical
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
| Applicant | Crosstex International, Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 16, 2008 |
| Received | Aug 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082258
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.