The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for High Pressure Connecting Sets.
| Device ID | K890208 |
| 510k Number | K890208 |
| Device Name: | HIGH PRESSURE CONNECTING SETS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | E-Z-EM, INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf E-Z-EM, INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-17 |
| Decision Date | 1989-05-19 |