510(k) K961342 ยท FXP Cover, Shoe, Operating-Room
SHOE COVER, NON-STERILE
| Applicant | Copioumed Intl., Inc., Green Valley AZ, US |
| Decision | Substantially Equivalent, Dec 30, 1996 |
| Received | Mar 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961342
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.