510(k) K071934

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT by Biomet Manufacturing Corp — Product Code JQC

K071934 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT". The FDA issued a decision of Substantially Equivalent on October 11, 2007. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.