FDA 510(k) Application Details - K120254

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K120254
Device Name Lamp, Infrared, Therapeutic Heating
Applicant THERASAGE CORPORATION
21000 Boca Rio Road,
Suite A21-C
BOCA RATON, FL 33433 US
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Contact ROBERT BESNER
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 01/27/2012
Decision Date 03/06/2012
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 Y
Expedited Review



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