Name: Predicase
Price: 199 USD

K-number	K041559
Device name	55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55
Applicant	Spire Biomedical, Inc.
Product code	MSD
Device class	Class II
Decision date	Jul 30, 2004
Decision	Unknown
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55

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