FDA 510(k) Application Details - K092589

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K092589
Device Name Lamp, Infrared, Therapeutic Heating
Applicant EAS CONSULTING GROUP LLC
1940 DUKE ST., SUITE 200
ALEXANDRIA, VA 22314 US
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Contact EDUARDO MARCH
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 08/24/2009
Decision Date 01/28/2010
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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