510(k) K955835 ยท FXP Cover, Shoe, Operating-Room
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
| Applicant | Instrument Makar, Inc., Okemos MI, US |
| Decision | Substantially Equivalent, Nov 19, 1996 |
| Received | Dec 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955835
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.