Name: Predicase
Price: 199 USD

K-number	K994321
Device name	STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
Applicant	Automatic Liquid Packaging, Inc.
Product code	JOL
Device class	Class II
Decision date	Oct 25, 2000
Decision	Substantially Equivalent
Regulation	880.6740

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

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