HydroMARK Breast Biopsy Site Markers

Marker, Radiographic, Implantable

Devicor Medical Products, Inc

The following data is part of a premarket notification filed by Devicor Medical Products, Inc with the FDA for Hydromark Breast Biopsy Site Markers.

Pre-market Notification Details

Device IDK203097
510k NumberK203097
Device Name:HydroMARK Breast Biopsy Site Markers
ClassificationMarker, Radiographic, Implantable
Applicant Devicor Medical Products, Inc 300 E-Business Way, Fifth Floor Cincinnati,  OH  45241
ContactRhonda M. Kops
CorrespondentRhonda M. Kops
Devicor Medical Products, Inc 300 E-Business Way, Fifth Floor Cincinnati,  OH  45241
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-14
Decision Date2020-12-16

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