Name: Predicase
Price: 199 USD

K-number	K073093
Device name	DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	Jan 22, 2008
Decision	Substantially Equivalent
Regulation	876.5540

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View the full FDA submission: accessdata.fda.gov

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DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,

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