K-number	K201799
Device name	CleaniCal
Applicant	Maruchi
Product code	EJK
Device class	Class II
Decision date	Feb 12, 2021
Decision	Substantially Equivalent
Regulation	872.3250

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Source

View the full FDA submission: accessdata.fda.gov

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CleaniCal

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