HydroMARK Breast Biopsy Site Marker

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 Marker.

Pre-market Notification Details

Device IDK212158
510k NumberK212158
Device Name:HydroMARK Breast Biopsy Site Marker
ClassificationMarker, Radiographic, Implantable
Applicant Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati,  OH  45241
ContactDiane Sung
CorrespondentDiane Sung
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 Received2021-07-12
Decision Date2022-04-21

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