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510(k) K160573

FirstSense Breast Exam by First Sense Medical, LLC — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2016
Date Received
February 29, 2016
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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