K-number	K223256
Device name	Optimos Cystotome
Applicant	Taewoong Medical Co., Ltd.
Product code	KNS
Device class	Class II
Decision date	Apr 5, 2023
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Optimos Cystotome

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Optimos Cystotome