510(k) K800528 ยท FXP Cover, Shoe, Operating-Room
SHIELD PERFECT FIT; DURA-FIT, DISPOS.
| Applicant | American Convertors Div., American Pharmaseal, Walker MI, US |
| Decision | Substantially Equivalent, Apr 16, 1980 |
| Received | Mar 7, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800528
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.