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510(k) K162767

Sentinel BreastScan II System by First Sense Medical, LLC — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2017
Date Received
September 30, 2016
Clearance Type
Special
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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