FDA 510(k) Application Details - K053376

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K053376
Device Name Lamp, Infrared, Therapeutic Heating
Applicant CHUNG CHENG ELECTRIC HEATING CO., LTD.
2904 N. BOLDT DRIVE
FLAGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/05/2005
Decision Date 02/16/2006
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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