Root Apex Locator

Locator, Root Apex

Foshan COXO Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Foshan Coxo Medical Instrument Co., Ltd. with the FDA for Root Apex Locator.

Pre-market Notification Details

Device IDK212178
510k NumberK212178
Device Name:Root Apex Locator
ClassificationLocator, Root Apex
Applicant Foshan COXO Medical Instrument Co., Ltd. BLDG 4, District A, Guangdong New Light Source Industrial Base, South Of Luocun Avenue, Nanhai District Foshan,  CN 528226
ContactYongjian Zheng
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeLQY  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2022-07-20

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