Name: Predicase
Price: 199 USD

K-number	K142153
Device name	HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
Applicant	Teleflexmedical, Inc.
Product code	CAF
Device class	Class II
Decision date	Apr 29, 2015
Decision	Substantially Equivalent
Regulation	868.5630

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Source

View the full FDA submission: accessdata.fda.gov

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HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML

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