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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 K090501
Device Name BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
Applicant
Biopsy Sciences, LLC
5582 Chalon Rd.
Yorba Linda,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
Biopsy Sciences, LLC
5582 Chalon Rd.
Yorba Linda,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number878.4300
Classification Product Code
NEU  
Date Received02/25/2009
Decision Date 03/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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