Name: Predicase
Price: 199 USD

K-number	K021212
Device name	24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	May 17, 2002
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

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