K-number	K223551
Device name	Sterile Water for Inhalation in 1L Flexoval ® bottles.
Applicant	Hometa, Inc.
Product code	BTT
Device class	Class II
Decision date	Aug 3, 2023
Decision	Substantially Equivalent
Regulation	868.5450

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View the full FDA submission: accessdata.fda.gov

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Sterile Water for Inhalation in 1L Flexoval ® bottles.

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