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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 K240081
Device Name Human Lubricant
Applicant
Jiangxi Wulinxiang Biological Technology Co., Ltd.
1f,Bldg. 1,Nanchang Led Industry Innovation Demonstration
Park, # 1111 Changdong Ave., Qingshan
Nanchang,  CN 330012
Applicant Contact Yang Qi
Correspondent
Jiangxi Wulinxiang Biological Technology Co., Ltd.
1f,Bldg. 1,Nanchang Led Industry Innovation Demonstration
Park, # 1111 Changdong Ave., Qingshan
Nanchang,  CN 330012
Correspondent Contact Yang Qi
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/11/2024
Decision Date 08/16/2024
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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