K-number	K200986
Device name	OPTI® B-Lac Cassette
Applicant	Opti Medical Systems, Inc.
Product code	CHL
Device class	Class II
Decision date	Aug 2, 2021
Decision	Substantially Equivalent
Regulation	862.1120

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Source

View the full FDA submission: accessdata.fda.gov

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OPTI® B-Lac Cassette

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