K-number	K910769
Device name	SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
Applicant	Surgitek Medical Engineering Corp.
Product code	ODD
Device class	Class II
Decision date	Jun 25, 1991
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM

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