The following data is part of a premarket notification filed by Rnd Medical Products, Inc. with the FDA for E.t. Strap #6000.
| Device ID | K830706 |
| 510k Number | K830706 |
| Device Name: | E.T. STRAP #6000 |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | RND MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-07 |
| Decision Date | 1983-04-28 |