K-number	K201877
Device name	OtoSet- Ear Cleaning System
Applicant	Safkan, Inc.
Product code	KYZ
Device class	Class I
Decision date	Nov 5, 2020
Decision	Substantially Equivalent
Regulation	880.6960

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Source

View the full FDA submission: accessdata.fda.gov

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OtoSet- Ear Cleaning System

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