510(k) K033373 ยท FMI Needle, Hypodermic, Single Lumen
MONOJECT INSULIN SYRINGE
| Applicant | Tyco Healthcare, Mansfield MA, US |
| Decision | Substantially Equivalent, Nov 13, 2003 |
| Received | Oct 22, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2008 | Covidien LP ReliOn Insulin syringes - 1cc, 31 G
Distributed by: Can-Am Care, Corp., Alpharetta, GA Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.