FDA 510(k) Application Details - K123177

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K123177
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LASERSTIM, INC.
8708 CAPEHART COVE
AUSTIN, TX 78733 US
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Contact DAVID C FURR
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 10/09/2012
Decision Date 07/03/2013
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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