The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Stylet Trachael Tube.
| Device ID | K905133 |
| 510k Number | K905133 |
| Device Name: | STYLET TRACHAEL TUBE |
| Classification | Stylet, Tracheal Tube |
| Applicant | MEDICAL DEVICES, INC. 952 SOUTH ZEPHYR COURT Lakewood, CO 80226 |
| Contact | David Chenoweth |
| Correspondent | David Chenoweth MEDICAL DEVICES, INC. 952 SOUTH ZEPHYR COURT Lakewood, CO 80226 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-15 |
| Decision Date | 1991-04-22 |