K-number	K220202
Device name	Uterine ElevatOR PRO with OccludOR Balloon
Applicant	The O R Company Pty, Ltd.
Product code	LKF
Device class	Class II
Decision date	Mar 31, 2022
Decision	Substantially Equivalent
Regulation	884.4530

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View the full FDA submission: accessdata.fda.gov

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Uterine ElevatOR PRO with OccludOR Balloon

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