510(k) K962001

MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE by Manan Medical Products, Inc. — Product Code FMI

K962001 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.