K-number	K180731
Device name	Ultramatrix EUS Balloon
Applicant	United States Endoscopy Group, Inc. (Us Endoscopy)
Product code	ODG
Device class	Class II
Decision date	Apr 19, 2018
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Ultramatrix EUS Balloon

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