FDA 510(k) Application Details - K062784

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K062784
Device Name Thermometer, Electronic, Clinical
Applicant SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
34 MCNAMARA STREET
STOUGHTON, MA 02072 US
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Contact PAUL WARE
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/18/2006
Decision Date 05/04/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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