K-number	K171223
Device name	Quantum TTC Biliary Balloon Dilator
Applicant	Wilson-Cook Medical, Inc.
Product code	FGE
Device class	Class II
Decision date	Jun 16, 2017
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum TTC Biliary Balloon Dilator

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