K-number	K241693
Device name	FemChec Controlled Saline-Air Device (FCD-250)
Applicant	Femasys, Inc.
Product code	LKF
Device class	Class II
Decision date	Sep 6, 2024
Decision	Substantially Equivalent
Regulation	884.4530

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View the full FDA submission: accessdata.fda.gov

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FemChec Controlled Saline-Air Device (FCD-250)

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