Name: Predicase
Price: 199 USD

K-number	K031676
Device name	HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
Applicant	Baxter Healthcare Corp
Product code	KDJ
Device class	Class II
Decision date	Nov 20, 2003
Decision	Substantially Equivalent
Regulation	876.5630

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Source

View the full FDA submission: accessdata.fda.gov

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HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q

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