FDA.report

510(k) K250629

Device
Sutil Rich Personal Lubricant
Applicant
Hathor Professional Skincare , Ltd.
510(k) number
K250629
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-02
Date received
2025-03-03
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
Carolyn (Mellta) Swift
Address
2618 Roseberry Ave. Victoria CA V8R 3T7 V8R 3T7

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K242645INA Moisturizing Intimate Lubricant Water-Based Personal LubricantProject Chemistry, Inc.2024-12-06