The following data is part of a premarket notification filed by Ecomed Solutions, Llc with the FDA for Ecomed Disposable Angiographic Syringes.
| Device ID | K162088 |
| 510k Number | K162088 |
| Device Name: | Ecomed Disposable Angiographic Syringes |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ECOMED SOLUTIONS, LLC 214 TERRACE DR Mundelein, IL 60060 |
| Contact | David Yurek |
| Correspondent | Christina Henza ULTRA LIFESCIENCE SOLUTIONS INC 146 N. GREENVIEW AVE Mundelein, IL 60060 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-28 |
| Decision Date | 2017-01-27 |
| Summary: | summary |