Name: Predicase
Price: 199 USD

K-number	K841718
Device name	FREKATHETER VENOUS CATHETERISATION SYS
Applicant	Fresenius USA, Inc.
Product code	—
Device class	Class unclassified
Decision date	Apr 25, 1984
Decision	Substantially Equivalent — with Special Conditions
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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FREKATHETER VENOUS CATHETERISATION SYS

Everything you need for a 510(k) submission. Nothing you don't.