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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 K013876
Device Name INFRARED EAR THERMOMETER, MODEL DX-707
Applicant
Jawon Medical Co., Ltd.
Jeong-Ju B/D 7f,1451-38,
Seocho-Dong
Seoul,  KR 137-070
Applicant Contact WON-HEE PARK
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact JOHN SO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/23/2001
Decision Date 03/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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