K-number	K181369
Device name	Immucise Intradermal Injection System
Applicant	Terumo Corporation
Product code	FMI
Device class	Class II
Decision date	Nov 13, 2018
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Immucise Intradermal Injection System

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