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FDA 510(k) Application Details - K012136
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K012136
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
Other 510(k) Applications for this Contact
Regulation Number
880.2910
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Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2001
Decision Date
09/10/2001
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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