The following data is part of a premarket notification filed by Laerdal California, Inc. with the FDA for Tracheal Tube Fixation Device.
| Device ID | K843790 |
| 510k Number | K843790 |
| Device Name: | TRACHEAL TUBE FIXATION DEVICE |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | LAERDAL CALIFORNIA, INC. 2841 EAST 19TH. STREET Long Beach , CA 90804 - |
| Contact | Geoffrey C Garth |
| Correspondent | Geoffrey C Garth LAERDAL CALIFORNIA, INC. 2841 EAST 19TH. STREET Long Beach , CA 90804 - |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1985-03-11 |