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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K010462
Device Name AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
Applicant
AVITA CORPORATION
900 N. SWITZER CANYON DR. #142
FLAGGSTAFF,  AZ  86001
Applicant Contact ALLEN REICH
Correspondent
AVITA CORPORATION
900 N. SWITZER CANYON DR. #142
FLAGGSTAFF,  AZ  86001
Correspondent Contact ALLEN REICH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/16/2001
Decision Date 04/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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