The following data is part of a premarket notification filed by Nemoto Kyorindo Co., Ltd. with the FDA for Rempress And Angiography Contrast Delivery System Rempress.
| Device ID | K092896 |
| 510k Number | K092896 |
| Device Name: | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | NEMOTO KYORINDO CO., LTD. 2-12-4 AOKI Kawaguchi-shi, Saitama, JP 332-0031 |
| Contact | Jim Knipfer |
| Correspondent | Jim Knipfer NEMOTO KYORINDO CO., LTD. 2-12-4 AOKI Kawaguchi-shi, Saitama, JP 332-0031 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560138481004 | K092896 | 000 |