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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
Device Name DYNATRON THERMOSTIM PROBE-DONE
Applicant
DYNATRONICS CORPORATION
7030 PARK CENTRE DRIVE
SALT LAKE CITY,  UT  84121
Applicant Contact DOUGLAS SAMPSON
Correspondent
DYNATRONICS CORPORATION
7030 PARK CENTRE DRIVE
SALT LAKE CITY,  UT  84121
Correspondent 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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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