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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 K210857
Device Name Personal Lubricant
Applicant
Shenzhen Huanqiu Xuebao Technology Co., Ltd.
Rm. 303, Bldg. 2, Ln. 2, Jinjuxia Rd., Bao'An Ave.
Fuyong St.
Bao'An District Shenzhen,  CN 518100
Applicant Contact Jiao Li
Correspondent
Wenzhou Thiwe Business Consulting Co., Ltd.
Rm. 1203, Bldg. C, Hua'Ou Jiayuan, # 50
Tangjiaqiao S. Rd.
Longwan District, Wenzhou,  CN 325000
Correspondent Contact Kevin Zhang
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/23/2021
Decision Date 09/24/2021
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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