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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K212158
Device Name HydroMARK Breast Biopsy Site Marker
Applicant
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati,  OH  45241
Applicant Contact Diane Sung
Correspondent
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati,  OH  45241
Correspondent Contact Diane Sung
Regulation Number878.4300
Classification Product Code
NEU  
Date Received07/12/2021
Decision Date 04/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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