The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Contrast Injection Device.
| Device ID | K880877 |
| 510k Number | K880877 |
| Device Name: | CONTRAST INJECTION DEVICE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
| Contact | David C Beattie |
| Correspondent | David C Beattie MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-05-31 |