K-number	K190591
Device name	Safergel Sterile Ultrasound Gel
Applicant	Safersonic Us, Inc.
Product code	MUI
Device class	Class II
Decision date	Oct 4, 2019
Decision	Substantially Equivalent
Regulation	892.1570

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Source

View the full FDA submission: accessdata.fda.gov

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Safergel Sterile Ultrasound Gel

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