K-number	K181811
Device name	ReTrace Ureteral Access Sheath
Applicant	Coloplast A/S
Product code	FED
Device class	Class II
Decision date	Sep 7, 2018
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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ReTrace Ureteral Access Sheath

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