510(k) K980211

MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES by Manan Medical Products, Inc. — Product Code KNW

K980211 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES". The FDA issued a decision of Substantially Equivalent on February 6, 1998. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.