FDA 510(k) Application Details - K011704

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K011704
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 06/01/2001
Decision Date 06/27/2001
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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