Name: Predicase
Price: 199 USD

K-number	K102936
Device name	HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
Applicant	Baxter Healthcare Corp
Product code	FKX
Device class	Class II
Decision date	Mar 30, 2011
Decision	Substantially Equivalent
Regulation	876.5630

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Source

View the full FDA submission: accessdata.fda.gov

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HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

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