Name: Predicase
Price: 199 USD

K-number	K063239
Device name	LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
Applicant	Hospira, Inc.
Product code	FPK
Device class	Class II
Decision date	Dec 11, 2006
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

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