510(k) K970440 ยท FXX Mask, Surgical
EKONIC DENTAL/MEDICAL MASK (MD 610)
| Applicant | Ekonic Company, Ltd., Carver MA, US |
| Decision | Substantially Equivalent, Mar 27, 1997 |
| Received | Feb 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970440
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.