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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 K251773
Device Name Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
Applicant
Shenzhen Yongquan Medical Devices Co., Ltd.
Rm. 309, Baiwangda Smart Park, Bantian, Longgang District
Shenzhen,  CN 518100
Applicant Contact Pei Ye
Correspondent
Huide Medical Technology Service Group Co., Ltd.
Rm. 703, Bldg. 16, S. Bank Plz., Exhibition Bay
Zhancheng Community, Fuhai St., Bao'An District
Shenzhen,  CN 518053
Correspondent Contact Tulin Li
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/10/2025
Decision Date 09/09/2025
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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