FDA 510(k) Application Details - K091158

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K091158
Device Name Lamp, Infrared, Therapeutic Heating
Applicant STELLAR LASERS
5401 S. COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
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Contact Kevin Walls
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 04/21/2009
Decision Date 08/10/2009
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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