Name: Predicase
Price: 199 USD

K-number	K150513
Device name	Imed Technology Intravascular Administration Set, Imed Technology Extension Set
Applicant	Imed Technology, Inc.
Product code	FPA
Device class	Class II
Decision date	May 28, 2015
Decision	Substantially Equivalent
Regulation	880.5440

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Imed Technology Intravascular Administration Set, Imed Technology Extension Set

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