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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 K854706
Device Name DIGITAL FASHION THERMOMETER
Applicant
Kanada Manufacturing Co., Ltd.
Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20011
Applicant Contact & HARTSON
Correspondent
Kanada Manufacturing Co., Ltd.
Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20011
Correspondent Contact & HARTSON
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/21/1985
Decision Date 01/16/1986
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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