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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K143267
Device Name TempTraq TT-100
Applicant
Blue Spark Technologies, Inc.
806 Sharon Dr., Suite G
Westlake,  OH  44145
Applicant Contact Jennifer Cartledge
Correspondent
Reu Associates, Inc.
409 Woodridge Dr.
Seneca,  SC  29672
Correspondent Contact Jennifer Cartledge
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/13/2014
Decision Date 09/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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