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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 K021028
Device Name MODEL GT980201 ELECTRONIC THERMOMETER
Applicant
Global Treasure , Ltd.
Block2, 5/F,. Rm. 8
Nan Fung Ind. City
18 Tin Hau Road, Tuen Mun N.T.,  HK
Applicant Contact BEN MA
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE JR.
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/29/2002
Decision Date 04/08/2002
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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