The following data is part of a premarket notification filed by Nemoto Kyorindo Co., Ltd. with the FDA for Contrast Delivery System - Dual Shot Alpha.
| Device ID | K062168 |
| 510k Number | K062168 |
| Device Name: | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA |
| Classification | Injector And Syringe, Angiographic |
| Applicant | NEMOTO KYORINDO CO., LTD. 2-27-20 HONGO BUNKYO-KU Tokyo, JP 123-0033 |
| Contact | Toshio Kanetaka |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-08-18 |
| Summary: | summary |