Name: Predicase
Price: 199 USD

K-number	K974471
Device name	PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
Applicant	Sims Deltec, Inc.
Product code	LJT
Device class	Class II
Decision date	Jan 22, 1998
Decision	Substantially Equivalent
Regulation	880.5965

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View the full FDA submission: accessdata.fda.gov

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PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A

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