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 |