FDA 510(k) Application Details - K032787

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K032787
Device Name Lamp, Infrared, Therapeutic Heating
Applicant SPECTRUM LASER & TECHNOLOGIES
4980 A CENTENNIAL BLVD.
COLORADO SPRINGS, CO 80919 US
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Contact THOMAS R RADEBAUGH
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 09/08/2003
Decision Date 11/20/2003
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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