510(k) K946027 ยท FMI Needle, Hypodermic, Single Lumen
BIG PHIL
| Applicant | Biomedical Waste Systems, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Jan 26, 1995 |
| Received | Dec 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946027
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.