Name: Predicase
Price: 199 USD

K-number	K030983
Device name	TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY
Applicant	Deltec, Inc.
Product code	MSD
Device class	Class II
Decision date	Apr 25, 2003
Decision	Unknown
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY

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