Name: Predicase
Price: 199 USD

K-number	K203032
Device name	IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
Applicant	Galil Medical, Inc.
Product code	GEH
Device class	Class II
Decision date	Nov 2, 2020
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle

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