FDA.report

510(k) K253983

Device
Water-based lubricant
Applicant
Guangzhou Haoyimai Trading Co., Ltd.
510(k) number
K253983
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-06
Date received
2025-12-12
Regulation
884.5300
Classification name
Lubricant, Personal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Coco Ling
Address
10th Floor, Bldg. B, Shiliushe Industrial Zone Xiamao Shixia Rd., Baiyunhu St., Baiyun District Guangzhou CN 510000 510000

FDA Registration Numbers

Source Documents

510(k) summary PDF

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