FDA 510(k) Application Details - K102149

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K102149
Device Name Lamp, Infrared, Therapeutic Heating
Applicant FOSHAN GAUNYING ELECTRONICS CO., LTD.
HI-TECH INDUSTRIAL DEVELOPMENT
FOSHAN, GUANGDONG 52800 CN
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Contact LADI LEE
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 07/30/2010
Decision Date 08/13/2010
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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