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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K143267
Device Name TempTraq TT-100
Applicant
Blue Spark Technologies Inc.
806 Sharon Drive, 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
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