The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Mlt Tube Microlaryngeal Tracheal Tube).
| Device ID | K801005 |
| 510k Number | K801005 |
| Device Name: | MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-28 |
| Decision Date | 1980-05-23 |