Name: Predicase
Price: 199 USD

K-number	K202006
Device name	ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
Applicant	ArthroCare Corporation
Product code	GEI
Device class	Class II
Decision date	Dec 18, 2020
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System

Everything you need for a 510(k) submission. Nothing you don't.