The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Uncuffed Hi-lo Jet Tracheal Tube.
| Device ID | K852493 |
| 510k Number | K852493 |
| Device Name: | UNCUFFED HI-LO JET TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls, NY 12301 |
| Contact | Philip E Wiegert |
| Correspondent | Philip E Wiegert MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls, NY 12301 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1985-07-08 |