FDA 510(k) Application Details - K150175

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K150175
Device Name Lamp, Infrared, Therapeutic Heating
Applicant HOME SKINOVATIONS LTD.
Tabor Building, Shaar Yokneam
Yoqneam Iillit 2069200 IL
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Contact Ahava Stein
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 01/26/2015
Decision Date 03/31/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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