Name: Predicase
Price: 199 USD

K-number	K060155
Device name	15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	May 9, 2006
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

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