Name: Predicase
Price: 199 USD

K-number	K070630
Device name	HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE
Applicant	Health Line International Corporation (Hlic)
Product code	FPA
Device class	Class II
Decision date	Aug 31, 2007
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE

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