FDA 510(k) Application Details - K033555

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K033555
Device Name Lamp, Infrared, Therapeutic Heating
Applicant KAYLIGHT CORPORATION
669 MAIN STREET SOUTH, STE 7
WOODBURY, CT 06798 US
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Contact DAVID R BALZER
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 11/12/2003
Decision Date 03/02/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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