510(k) K971191 ยท FXP Cover, Shoe, Operating-Room
FAR-EAST SHOE COVERS
| Applicant | Far East Science & Technology Development Co., Ltd., Garden Grove CA, US |
| Decision | Substantially Equivalent, Jul 10, 1997 |
| Received | Mar 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971191
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.