FDA 510(k) Application Details - K142722

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K142722
Device Name Lamp, Infrared, Therapeutic Heating
Applicant Livetec GMBH
Marie-Curie-Str. 8
Loerrach D 79539 DE
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Contact Klaus Reichenbach
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 09/23/2014
Decision Date 01/13/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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