The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Roentgenography Set.
| Device ID | K830229 |
| 510k Number | K830229 |
| Device Name: | ROENTGENOGRAPHY SET |
| Classification | Igg, Ferritin, Antigen, Antiserum, Control |
| Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DGD |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-24 |
| Decision Date | 1983-03-09 |