510(k) K100665

MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX by Needle Tech Products, Inc. — Product Code FMF

K100665 is an FDA 510(k) premarket notification submitted by Needle Tech Products, Inc. for the device "MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX". The FDA issued a decision of Substantially Equivalent on June 24, 2010. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Needle Tech Products, Inc. has at least 2 other 510(k) clearances on record.