LUBi Water Based Personal Lubricant

Lubricant, Personal

Boya Biotechnology Co., Ltd.

The following data is part of a premarket notification filed by Boya Biotechnology Co., Ltd. with the FDA for Lubi Water Based Personal Lubricant.

Pre-market Notification Details

Device IDK203257
510k NumberK203257
Device Name:LUBi Water Based Personal Lubricant
ClassificationLubricant, Personal
Applicant Boya Biotechnology Co., Ltd. Floor3,#7, Changfu Rd., Ludong Community, Humen Town Dongguan,  CN 523935
ContactJason Lau
CorrespondentJoyce Yang
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen,  CN 518100
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-04
Decision Date2020-12-23

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