FDA 510(k) Application Details - K954577

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K954577
Device Name Lamp, Infrared, Therapeutic Heating
Applicant C.A.I. INDUSTRIES CORP.
307 W. MAIN ST., SUITE 10
ALHAMBRA, CA 91801 US
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Contact LU RAO
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 10/02/1995
Decision Date 05/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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