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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K212104
Device Name Water-soluble Personal Lubricant
Applicant
Foshan Pingchuang Medical Technology Co., Ltd.
Rm. 301, # 3, Huaye Rd., Lingang Pioneer Park,
Shunjiang Neighborhood Committee, Beijiao
Foshan,  CN 528312
Applicant Contact Huang Zhiyue
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq., Nanshan
District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/06/2021
Decision Date 11/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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