510(k) K971076 ยท FXP Cover, Shoe, Operating-Room
PRIMED SHOE COVERS, PRIMED HEAD COVERS
| Applicant | Primeline Medical Products, Inc., Alberta, CA |
| Decision | Substantially Equivalent, Jan 13, 1998 |
| Received | Mar 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971076
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.