Name: Predicase
Price: 199 USD

K-number	K000964
Device name	STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
Applicant	Automatic Liquid Packaging, Inc.
Product code	JOH
Device class	Class II
Decision date	Apr 25, 2000
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109

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