Name: Predicase
Price: 199 USD

K-number	K022000
Device name	POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	Jul 19, 2002
Decision	Substantially Equivalent
Regulation	876.5540

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View the full FDA submission: accessdata.fda.gov

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POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)

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