Name: Predicase
Price: 199 USD

K-number	K010426
Device name	PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
Applicant	Sims Deltec, Inc.
Product code	LJT
Device class	Class II
Decision date	Mar 8, 2001
Decision	Substantially Equivalent
Regulation	880.5965

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Source

View the full FDA submission: accessdata.fda.gov

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PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER

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