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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, mammographic
510(k) Number K113284
Device Name BIOPSY POSITIONER
Applicant
FUJI FILM MEDICAL SYSTEMS
419 WEST AVE.
STAMFORD,  CT  06902
Applicant Contact KIMERLY A SHARP
Correspondent
FUJI FILM MEDICAL SYSTEMS
419 WEST AVE.
STAMFORD,  CT  06902
Correspondent Contact KIMERLY A SHARP
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/07/2011
Decision Date 03/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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