FDA 510(k) Application Details - K023412

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K023412
Device Name Thermometer, Electronic, Clinical
Applicant HUBDIC CO., LTD
11820 RED HIBISCUS DR.
BONITA SPRINGS, FL 34135 US
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Contact GUENTER GINSBERG
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 10/11/2002
Decision Date 04/09/2003
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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