FDA 510(k) Application Details - K131080

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K131080
Device Name Lamp, Infrared, Therapeutic Heating
Applicant REIMERS AND JANSSEN GMBH
FABRIKSTR. 22
WALDKIRCH, BADEN WURTHEMBERG 79183 DE
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Contact JOSEPHUS JANSSEN
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 03/25/2013
Decision Date 06/13/2014
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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