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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 K030361
Device Name JASUN, MODELS DT-01F AND DT-11F
Applicant
Hangzhou Hua'An Medical & Health Instruments Co.,
4960 Tamarack Dr.
Barrington,  IL  60010
Applicant Contact TING LU
Correspondent
Hangzhou Hua'An Medical & Health Instruments Co.,
4960 Tamarack Dr.
Barrington,  IL  60010
Correspondent Contact TING LU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/03/2003
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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