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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 K021851
Device Name DIGITAL CLINICAL THERMOMETER, MODEL KD-193
Applicant
K-Jump Health Co., Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
K-Jump Health Co., Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/05/2002
Decision Date 07/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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