The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Angiographic Control Syringe.
| Device ID | K093830 |
| 510k Number | K093830 |
| Device Name: | MEDLINE ANGIOGRAPHIC CONTROL SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clasen |
| Correspondent | Matt Clasen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE 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 | 2009-12-14 |
| Decision Date | 2011-03-03 |