FDA 510(k) Application Details - K024361

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K024361
Device Name Lamp, Infrared, Therapeutic Heating
Applicant EM PROBE INC.
1501 OLD GARDINER RD.
SEQUIM, WA 98382 US
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Contact GLEN A GORDON
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/30/2002
Decision Date 10/09/2003
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 N
Expedited Review



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