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 IDK161021
510k NumberK161021
Device Name:HydroMARK Breast Biopsy Site Marker
ClassificationMarker, Radiographic, Implantable
Applicant DEVICOR MEDICAL PRODUCTS, INC. 300 E-BUSINESS WAY, FIFTH FLOOR Cincinnati,  OH  45241
ContactShawna Rose
CorrespondentShawna Rose
DEVICOR MEDICAL PRODUCTS, INC. 300 E-BUSINESS WAY, FIFTH FLOOR Cincinnati,  OH  45241
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-12
Decision Date2016-05-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841911101519 K161021 000
10841911101502 K161021 000
10841911100147 K161021 000
10841911100130 K161021 000
10841911102318 K161021 000
10841911102301 K161021 000
10841911102196 K161021 000
10841911102189 K161021 000

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