FDA 510(k) Application Details - K080084

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K080084
Device Name Lamp, Infrared, Therapeutic Heating
Applicant CELL GEN THERAPEUTICS, LLC
17734 PRESTON ROAD
SUITE 204
DALLAS, TX 75252 US
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Contact DICK RIVERA
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 01/11/2008
Decision Date 04/21/2008
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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