FDA 510(k) Application Details - K102935

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K102935
Device Name Thermometer, Electronic, Clinical
Applicant KINGTECH ENTERPRISE, LTD.
FARM VILLAGE
DALINGSHAN TOWN
DONGUAN CN
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Contact JEN KE-MIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 10/04/2010
Decision Date 05/27/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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