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510(k) Data Aggregation

K Number

Device Name

Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)

Manufacturer

Shenzhen Yongquan Medical Devices Co., Ltd.

Date Cleared

2025-09-09

(91 days)

Product Code

Regulation Number

Type

Panel

Obstetrics and Gynecology (OB)

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

Shenzhen Yongquan Medical Devices Co., Ltd.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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