The following data is part of a premarket notification filed by Nemoto Kyorindo Co., Ltd. with the FDA for Dual Shot Alpha 7.
| Device ID | K133189 |
| 510k Number | K133189 |
| Device Name: | DUAL SHOT ALPHA 7 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | NEMOTO KYORINDO CO., LTD. 2-27-20 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Contact | Ken Wakabayashi |
| Correspondent | Ken Wakabayashi NEMOTO KYORINDO CO., LTD. 2-27-20 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560138481707 | K133189 | 000 |