FDA 510(k) Application Details - K061614

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K061614
Device Name Lamp, Infrared, Therapeutic Heating
Applicant ESCADA INTERNATIONAL, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 06/09/2006
Decision Date 10/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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