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510(k) K113284

BIOPSY POSITIONER by Fuji Film Medical Systems — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2012
Date Received
November 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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