K-number	K233689
Device name	Hope&Her Vaginal Dilators
Applicant	Lujena, Inc.
Product code	HDX
Device class	Class II
Decision date	May 2, 2024
Decision	Substantially Equivalent
Regulation	884.3900

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Source

View the full FDA submission: accessdata.fda.gov

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Hope&Her Vaginal Dilators

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