Name: Predicase
Price: 199 USD

K-number	K153329
Device name	MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
Applicant	Med-Tech Water Systems, Inc.
Product code	FIP
Device class	Class II
Decision date	Aug 4, 2016
Decision	Substantially Equivalent
Regulation	876.5665

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Source

View the full FDA submission: accessdata.fda.gov

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MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

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