FDA 510(k) Application Details - K070516

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K070516
Device Name Lamp, Infrared, Therapeutic Heating
Applicant POWERMEDIC APS
KANALSTRAEDE 2
HOLBAEK DK-4300 DK
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Contact ARNE GRINSTED
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 02/22/2007
Decision Date 07/02/2007
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 N
Expedited Review



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