510(k) K071459 ยท FMF Syringe, Piston
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Aug 16, 2007 |
| Received | May 25, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2009 | I-Flow Corporation B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr
Used to provide an optional filling device for the Easypump. Terminated |
FMF | None listed |
| Sep 24, 2009 | I-Flow Corporation B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.