510(k) K971744 ยท FXX Mask, Surgical
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
| Applicant | Berkley Medical Resources, Inc., Asheville NC, US |
| Decision | Substantially Equivalent, Jul 28, 1997 |
| Received | May 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971744
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.