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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 K992327
Device Name DUTECK DIGITAL CLINICAL THERMOMETER
Applicant
Duteck Industrial Co., Ltd.
900 N. Switzer Dr. #142
Flaggstaff,  AZ  86001
Applicant Contact ALLEN REICH
Correspondent
Duteck Industrial Co., Ltd.
900 N. Switzer Dr. #142
Flaggstaff,  AZ  86001
Correspondent Contact ALLEN REICH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/12/1999
Decision Date 08/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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