The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Immucise Intradermal Injection System.
Device ID | K181369 |
510k Number | K181369 |
Device Name: | Immucise Intradermal Injection System |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-ku,, JP 151-0072 |
Contact | Yuko Watanabe |
Correspondent | Vaarghese Phebe Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-23 |
Decision Date | 2018-11-13 |
Summary: | summary |