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510(k) K123442

XOFT AXXENT CERVICAL APPLICATORS by Icad, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2013
Date Received
November 8, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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