510(k) K913628 ยท FXP Cover, Shoe, Operating-Room
DISPOSABLE SHOE COVER
| Applicant | Gem Nonwovews, Inc., Huntsville AL, US |
| Decision | Substantially Equivalent, Oct 4, 1991 |
| Received | Aug 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913628
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.