The following data is part of a premarket notification filed by Sontek Industries, Inc. with the FDA for Tube-title.
| Device ID | K833361 |
| 510k Number | K833361 |
| Device Name: | TUBE-TITLE |
| Classification | Support, Breathing Tube |
| Applicant | SONTEK INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAY |
| CFR Regulation Number | 868.5280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1983-11-03 |