Name: Predicase
Price: 199 USD

K-number	K042858
Device name	55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	Dec 3, 2004
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS

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