510(k) K894383 ยท FXP Cover, Shoe, Operating-Room
DISPOSABLE SHOE COVER
| Applicant | American Threshold Industries, Inc., Enka NC, US |
| Decision | Substantially Equivalent, Sep 12, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894383
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.