Name: Predicase
Price: 199 USD

K-number	K974829
Device name	NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
Applicant	Kawasumi Laboratories Co., Ltd.
Product code	LJT
Device class	Class II
Decision date	Feb 12, 1998
Decision	Substantially Equivalent
Regulation	880.5965

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Source

View the full FDA submission: accessdata.fda.gov

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NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)

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