YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

Thermometer, Electronic, Clinical

YU LONG SHENG TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Yu Long Sheng Technology Co., Ltd with the FDA for Yu Long Sheng Disposable Thermometer Sheaths, Models Yls-01 And Yls-02.

Pre-market Notification Details

Device IDK102508
510k NumberK102508
Device Name:YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
ClassificationThermometer, Electronic, Clinical
Applicant YU LONG SHENG TECHNOLOGY CO., LTD NO. 15, ALLEY 71, CHENPING 1ST BEITUN DISTRICT Taichung,  TW 406
ContactTony C Chang
CorrespondentTony C Chang
YU LONG SHENG TECHNOLOGY CO., LTD NO. 15, ALLEY 71, CHENPING 1ST BEITUN DISTRICT Taichung,  TW 406
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-01
Decision Date2011-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00634782562762 K102508 000
10767056182506 K102508 000
10767056181509 K102508 000
30096295130066 K102508 000

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