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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 K203257
Device Name LUBi Water Based Personal Lubricant
Applicant
Boya Biotechnology Co., Ltd.
Floor3,#7, Changfu Rd., Ludong Community, Humen Town
Dongguan,  CN 523935
Applicant Contact Jason Lau
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 Received11/04/2020
Decision Date 12/23/2020
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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