The following data is part of a premarket notification filed by Nemoto Kyorindo Co., Ltd. with the FDA for Press Duo Elite, Press Duo Elite Ag.
| Device ID | K173450 |
| 510k Number | K173450 |
| Device Name: | PRESS DUO Elite, PRESS DUO Elite AG |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Nemoto Kyorindo Co., Ltd. 2-27-20 Hongo Bunkyo-ku, JP 113-0033 |
| Contact | Jim Knipfer |
| Correspondent | Jim Knipfer Nemoto Kyorindo Co., Ltd. 2-27-20 Hongo Bunkyo-ku, JP 113-0033 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-06 |
| Decision Date | 2018-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560138482605 | K173450 | 000 |