The following data is part of a premarket notification filed by Forma Scientific, Inc. with the FDA for Mallinckrodt Diag. Media Warmer.
| Device ID | K821401 |
| 510k Number | K821401 |
| Device Name: | MALLINCKRODT DIAG. MEDIA WARMER |
| Classification | Injector And Syringe, Angiographic |
| Applicant | FORMA SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-11 |
| Decision Date | 1982-06-17 |