Immucise Intradermal Injection System

Needle, Hypodermic, Single Lumen

Terumo Corporation

The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Immucise Intradermal Injection System.

Pre-market Notification Details

Device IDK181369
510k NumberK181369
Device Name:Immucise Intradermal Injection System
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-ku,,  JP 151-0072
ContactYuko Watanabe
CorrespondentVaarghese Phebe
Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset,  NJ  08873
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-23
Decision Date2018-11-13
Summary:summary

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