Water-soluble Personal Lubricant

Lubricant, Personal

Foshan PingChuang Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Foshan Pingchuang Medical Technology Co., Ltd. with the FDA for Water-soluble Personal Lubricant.

Pre-market Notification Details

Device IDK212104
510k NumberK212104
Device Name:Water-soluble Personal Lubricant
ClassificationLubricant, Personal
Applicant Foshan PingChuang Medical Technology Co., Ltd. Room 301, No. 3, Huaye Road, Lingang Pioneer Park, Shunjiang Neighborhood Committee, Beijiao Foshan,  CN 528312
ContactHuang Zhiyue
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 Received2021-07-06
Decision Date2021-11-18

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