DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES

Electrosurgical, Cutting & Coagulation & Accessories

SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD.

The following data is part of a premarket notification filed by Shuyou Electric Medical Science Co., Ltd. with the FDA for Disposable Grounding Pad Series And Electrode Series.

Pre-market Notification Details

Device IDK091672
510k NumberK091672
Device Name:DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai,  CN 200030
ContactDiana Hong
CorrespondentDiana Hong
SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai,  CN 200030
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-09
Decision Date2009-12-04
Summary:summary

NIH GUDID Devices

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