The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Foam Nose.
| Device ID | K840399 |
| 510k Number | K840399 |
| Device Name: | FOAM NOSE |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-30 |
| Decision Date | 1984-03-16 |