K-number	K010068
Device name	RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
Applicant	Rusch Intl.
Product code	ESW
Device class	Class II
Decision date	Feb 8, 2001
Decision	Substantially Equivalent
Regulation	878.3610

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View the full FDA submission: accessdata.fda.gov

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RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM

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