FDA 510(k) Application Details - K051835

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K051835
Device Name Thermometer, Electronic, Clinical
Applicant NORM PACIFIC AUTOMATION CORP.
3F, NO. 31, HU-PIN ROAD #1
SBIP
HSIN-CHU TW
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Contact CHI-CHU WU CHEN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 07/06/2005
Decision Date 09/23/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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