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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 K080759
Device Name THERMOFLASH LX-26
Applicant
Jxb Co. Ltd Guangzhou (China)
No 38 Huanzhen Xi Rd.
Dagang Town
Panuy, Guangzhou,  CN
Applicant Contact TRAY CUI
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/18/2008
Decision Date 05/12/2008
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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