K-number	K201138
Device name	AMSure® Single Use Saline Topical Solution
Applicant	Amsino Medical, Inc.
Product code	FRO
Device class	Class U
Decision date	Apr 14, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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AMSure® Single Use Saline Topical Solution

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