510(k) K170803

HydroMARK Breast Biopsy Site Markers by Devicor Medical Products, Inc. — Product Code NEU

K170803 is an FDA 510(k) premarket notification submitted by Devicor Medical Products, Inc. for the device "HydroMARK Breast Biopsy Site Markers". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Devicor Medical Products, Inc. has at least 10 other 510(k) clearances on record.