510(k) K943034 ยท FXP Cover, Shoe, Operating-Room
OREX SHOE COVERS
| Applicant | Thantex Specialties, Inc., Herndon VA, US |
| Decision | Substantially Equivalent, Jan 2, 1995 |
| Received | Jun 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943034
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.