K-number	K213207
Device name	Sheath, Stopcock Accessory
Applicant	Olympus Winter & Ibe GmbH
Product code	HIH
Device class	Class II
Decision date	Dec 22, 2021
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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Sheath, Stopcock Accessory

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