FDA 510(k) Application Details - K113250

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K113250
Device Name Lamp, Infrared, Therapeutic Heating
Applicant DYNATRONICS CORP.
7030 PARK CENTRE DR.
SALT LAKE CITY, UT 84121 US
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Contact DOUGLAS SAMPSON
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 11/03/2011
Decision Date 02/09/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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