FDA 510(k) Application Details - K073352

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K073352
Device Name Lamp, Infrared, Therapeutic Heating
Applicant WEBER MEDICAL GMBH
SOHNREYSTRASSE 6
LAURENFORDE, NIEDERSACHSEN 37697 DE
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Contact JURGEN HERMANN
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 11/29/2007
Decision Date 08/11/2008
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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