The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Elph Injection System.
| Device ID | K022116 |
| 510k Number | K022116 |
| Device Name: | ELPH INJECTION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Contact | Ellis Rogers |
| Correspondent | Ellis Rogers MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-01 |
| Decision Date | 2002-07-26 |
| Summary: | summary |