FDA 510(k) Application Details - K043558

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K043558
Device Name Lamp, Infrared, Therapeutic Heating
Applicant CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
1800 CENTURY PARK E, STE 600
CENTURY CITY, CA 90067 US
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Contact GEORGE SU
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/27/2004
Decision Date 06/06/2005
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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