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510(k) K113259

NOTOUCH BREASTSCAN by Ue Lifesciences, Inc. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2012
Date Received
November 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type

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