510(k) K071934 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 11, 2007 |
| Received | Jul 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2009 | Biomet, Inc. Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800 Terminated |
JQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.