FDA 510(k) Application Details - K002182

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K002182
Device Name Thermometer, Electronic, Clinical
Applicant AVITA CORPORATION
900 N. SWITZER CANYON 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 07/19/2000
Decision Date 12/29/2000
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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