Name: Predicase
Price: 199 USD

K-number	K053512
Device name	HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
Applicant	Baxter Healthcare Corp
Product code	FKX
Device class	Class II
Decision date	Feb 16, 2006
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 PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310

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