K-number	K220934
Device name	RADIFOCUS Torque Device
Applicant	Terumo Medical Products (Hangzhou) Co., Ltd.
Product code	MOF
Device class	Class II
Decision date	Jun 29, 2022
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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RADIFOCUS Torque Device

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