The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Disposable Angiographic Syringes For Use With Nemoto Angiographic Power, Model Sy-125, C855-5150.
| Device ID | K090487 |
| 510k Number | K090487 |
| Device Name: | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR, INC. 704 CADET COURT Lebanon, TN 37087 |
| Contact | Debra Manning |
| Correspondent | Debra Manning COEUR, INC. 704 CADET COURT Lebanon, TN 37087 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-10-19 |