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510(k) K073262

BELLA by Beekley Corp. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2008
Date Received
November 20, 2007
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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