Name: Predicase
Price: 199 USD

K-number	K022747
Device name	HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
Applicant	Hydropure Systems, Inc.
Product code	FIP
Device class	Class II
Decision date	Feb 11, 2003
Decision	Substantially Equivalent
Regulation	876.5665

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Source

View the full FDA submission: accessdata.fda.gov

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HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM

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