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510(k) K032350

INFRARED SCIENCES BREASTSCAN IR SYSTEM by Infrared Sciences Corp. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
July 30, 2003
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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