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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 K243107
Device Name Water Solubility Human Body Lubricant
Applicant
Dongguan Yanxuan Biotechnology Co., Ltd.
Rm. 203, # 509, Shenyuan 1st Lane, Qiaotou Town
Dongguang,  CN
Applicant Contact Wang Long
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Square
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Joyce Yang
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/30/2024
Decision Date 05/09/2025
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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