K-number	K101113
Device name	GUARDIAN II NC HEMOSTASIS VALVE
Applicant	Zerusa Limited
Product code	DTL
Device class	Class II
Decision date	May 21, 2010
Decision	Substantially Equivalent
Regulation	870.4290

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Source

View the full FDA submission: accessdata.fda.gov

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GUARDIAN II NC HEMOSTASIS VALVE

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