510(k) K943626 ยท FMI Needle, Hypodermic, Single Lumen
ISOLYSER SHARPS MANAGEMENT SYSTEM SMS
| Applicant | Thantex Specialties, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Jun 16, 1995 |
| Received | Jul 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943626
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.