FDA 510(k) Application Details - K012508

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K012508
Device Name Lamp, Infrared, Therapeutic Heating
Applicant NU PHOTONICS, INC.
666 BRYANT ST.
DENVER, CO 80204 US
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Contact WILLIAM M BROCK
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 08/06/2001
Decision Date 10/09/2001
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 Y
Expedited Review



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