FDA 510(k) Application Details - K073681

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K073681
Device Name Lamp, Infrared, Therapeutic Heating
Applicant DAVARAY, INC.
2232 SOUTH MAIN STREET
SUITE 422
ANN ARBOR, MI 48103 US
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Contact DAVID J ARNDT
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/28/2007
Decision Date 12/09/2008
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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