The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Or Tube Restraint.
| Device ID | K851874 |
| 510k Number | K851874 |
| Device Name: | OR TUBE RESTRAINT |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | KINETIC CONCEPTS, INC. 4958 STOUT DR. San Antonio, TX 78219 |
| Contact | Robert A Nehrmeyer |
| Correspondent | Robert A Nehrmeyer KINETIC CONCEPTS, INC. 4958 STOUT DR. San Antonio, TX 78219 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-29 |
| Decision Date | 1985-08-08 |