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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cutaneous
510(k) Number K120835
Models DQ7FP, DQ7RP
Device Name DYNATRON THERMOSTIM PROBE-DONE
Original Applicant
DYNATRONICS CORPORATION
7030 park centre drive
salt lake city,  UT  84121
Original Contact douglas sampson
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
ILO  
Date Received03/20/2012
Decision Date 08/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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