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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name post breast biopsy hemostatic breast compression device
510(k) Number K163388
Device Name XPress BCD Breast Compression Device
Applicant
XPress BCD, LLC
6024 White Flint Drive
Frederick,  MD  21702
Applicant Contact Peter Kremers
Correspondent
XPress BCD, LLC
6024 White Flint Drive
Frederick,  MD  21702
Correspondent Contact Peter Kremers
Regulation Number892.1710
Classification Product Code
POY  
Date Received12/02/2016
Decision Date 07/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02327598
Reviewed by Third Party No
Combination Product No
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