FDA 510(k) Application Details - K120835

Device Classification Name Electrode, Cutaneous

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510(K) Number K120835
Device Name Electrode, Cutaneous
Applicant DYNATRONICS CORPORATION
7030 PARK CENTRE DRIVE
SALT LAKE CITY, UT 84121 US
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Contact DOUGLAS SAMPSON
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 03/20/2012
Decision Date 08/20/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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