FDA 510(k) Application Details - K060792

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K060792
Device Name Lamp, Infrared, Therapeutic Heating
Applicant PHOTOACTIF, LLC
1959 SOUTH POWER RD
SUITE 103-313
MESA, AZ 85206 US
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Contact JEREMY SHELLMAN
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 03/23/2006
Decision Date 12/01/2006
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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