FDA 510(k) Application Details - K030324

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K030324
Device Name Thermometer, Electronic, Clinical
Applicant RADIANT INNOVATION, INC.
NO. 40 LANE 19, BADE RD.
HSINCHU CITY 300 TW
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Contact CHARLES CHANG
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 01/31/2003
Decision Date 02/27/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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