FDA 510(k) Application Details - K092958

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K092958
Device Name Thermometer, Electronic, Clinical
Applicant AVITA CORPORATION
2904 N. BOLDT DR.
FLAGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/25/2009
Decision Date 12/02/2009
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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