K-number	K182565
Device name	AtriCure cryoICE cryoSPHERE cryoablation probe
Applicant	AtriCure, Inc.
Product code	GXH
Device class	Class II
Decision date	Nov 9, 2018
Decision	Substantially Equivalent
Regulation	882.4250

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View the full FDA submission: accessdata.fda.gov

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AtriCure cryoICE cryoSPHERE cryoablation probe

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