FDA 510(k) Application Details - K103617

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K103617
Device Name Thermometer, Electronic, Clinical
Applicant K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
WU KU INDUSTRIAL PARK
TAIPEI HSIEN 248 TW
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Contact JASON CHENG
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 12/10/2010
Decision Date 04/04/2011
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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