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510(k) K071787

BEMITT, MODEL 0001 by Dja Distributors, LLC — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2007
Date Received
July 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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