FDA 510(k) Application Details - K050022

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K050022
Device Name Lamp, Infrared, Therapeutic Heating
Applicant MEDX ELECTRONICS, INC.
3350 RIDGEWAY DRIVE UNIT 3
MISSISSAUGA ON L5L 5Z9 CA
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Contact ANITA SALTMARCHE
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 01/05/2005
Decision Date 05/05/2005
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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