FDA 510(k) Application Details - K021028

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K021028
Device Name Thermometer, Electronic, Clinical
Applicant GLOBAL TREASURE LTD.
BLOCK2, 5/F,. ROOM 8
NAN FUNG IND. CITY
18 TIN HAU ROAD, TUEN MUN N.T. HK
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Contact BEN MA
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 03/29/2002
Decision Date 04/08/2002
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 Y
Expedited Review



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