FDA 510(k) Application Details - K141564

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K141564
Device Name Lamp, Infrared, Therapeutic Heating
Applicant ZIMMER MEDIZINSYSTEMS GMBH
JUNKERSSTRASSE 9
NEU-ULM 89231 DE
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Contact ARMIN PETRASCHKA
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 06/12/2014
Decision Date 10/24/2014
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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