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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 K121113
Device Name BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
Original Applicant
BIOPSY SCIENCES, LLC
5582 chalon rd.
yorba linda,  FL  33760
Original Contact sharon rockwell
Regulation Number878.4300
Classification Product Code
NEU  
Date Received04/12/2012
Decision Date 07/12/2012
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
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