K-number	K983154
Device name	CYSTIC DUCT BALLOON DILATING CATHETER
Applicant	Applied Medical Resources
Product code	FGE
Device class	Class II
Decision date	May 5, 1999
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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CYSTIC DUCT BALLOON DILATING CATHETER

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