Name: Predicase
Price: 199 USD

K-number	K073092
Device name	DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	Jan 29, 2008
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,

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