FDA 510(k) Application Details - K070690

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K070690
Device Name Lamp, Infrared, Therapeutic Heating
Applicant COTTONWOOD VESSEL CORPORATION
800 CONNECTICUT AVE., NW
WASHINGTON, DC 20006 US
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Contact MIKI KOLTON
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 03/13/2007
Decision Date 11/16/2007
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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