K-number	K201815
Device name	Dornier MAGELLAN Ureteral Access Sheath
Applicant	Dornier Medtech America, Inc.
Product code	FED
Device class	Class II
Decision date	Nov 20, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Dornier MAGELLAN Ureteral Access Sheath

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