The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Stabiltrach.
| Device ID | K935171 |
| 510k Number | K935171 |
| Device Name: | STABILTRACH |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Contact | John D Calebaugh |
| Correspondent | John D Calebaugh B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1993-12-02 |