The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Ct 8000 Digital Injection System.
| Device ID | K912944 |
| 510k Number | K912944 |
| Device Name: | CT 8000 DIGITAL INJECTION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | Mark L Freidman |
| Correspondent | Mark L Freidman MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-05 |
| Decision Date | 1992-02-04 |