K-number	K231430
Device name	Intimate Rose Vaginal Dilators
Applicant	Plus EV Holdings Dba Intimate Rose
Product code	HDX
Device class	Class II
Decision date	Jun 7, 2023
Decision	Substantially Equivalent
Regulation	884.3900

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Source

View the full FDA submission: accessdata.fda.gov

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Intimate Rose Vaginal Dilators

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