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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K012136
Device Name AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
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 Received07/09/2001
Decision Date 09/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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