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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 K102508
Device Name YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
Applicant
Yu Long Sheng Technology Co., Ltd.
# 15, Aly. 71, Chenping 1st
Beitun District
Taichung,  TW 406
Applicant Contact TONY C CHANG
Correspondent
Yu Long Sheng Technology Co., Ltd.
# 15, Aly. 71, Chenping 1st
Beitun District
Taichung,  TW 406
Correspondent Contact TONY C CHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/01/2010
Decision Date 01/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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