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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name locator, root apex
510(k) Number K212178
Device Name Root Apex Locator
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
Applicant Contact Yongjian Zheng
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Classification Product Code
LQY  
Date Received07/12/2021
Decision Date 07/20/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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