K-number	K181741
Device name	IceSphere 1.5 CX Cryoablation Needle
Applicant	Galil Medical , Ltd.
Product code	GEH
Device class	Class II
Decision date	Jul 30, 2018
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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IceSphere 1.5 CX Cryoablation Needle

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