FDA 510(k) Application Details - K992327

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K992327
Device Name Thermometer, Electronic, Clinical
Applicant DUTECK INDUSTRIAL CO., LTD.
900 N. SWITZER DR. #142
FLAGGSTAFF, AZ 86001 US
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Contact ALLEN REICH
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 07/12/1999
Decision Date 08/18/1999
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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