K-number	K212667
Device name	Single Use Guide Sheath Kit-401, K-402
Applicant	Olympus Medical Systems Corp.
Product code	EOQ
Device class	Class II
Decision date	Sep 22, 2021
Decision	Substantially Equivalent
Regulation	874.4680

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Source

View the full FDA submission: accessdata.fda.gov

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Single Use Guide Sheath Kit-401, K-402

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