K-number	K102485
Device name	RE-TRACE URETERAL ACCESS SHEATH
Applicant	Coloplast A/S
Product code	FED
Device class	Class II
Decision date	Oct 18, 2010
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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RE-TRACE URETERAL ACCESS SHEATH

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