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510(k) K161575

Affirm Lateral Arm Upright Biopsy Accessory by Hologic — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2016
Date Received
June 7, 2016
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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