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510(k) K101373

EMBRACE by Izi Medical Products, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
May 17, 2010
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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