FDA 510(k) Application Details - K014208

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K014208
Device Name Lamp, Infrared, Therapeutic Heating
Applicant RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC.
8303 S.W. FREEWAY, STE 835
HOUSTON, TX 77074-1601 US
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Contact JOYCE HEINRICH
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/21/2001
Decision Date 07/02/2002
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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