The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Trach-collar.
| Device ID | K782002 |
| 510k Number | K782002 |
| Device Name: | TRACH-COLLAR |
| Classification | Laryngoscope, Nasopharyngoscope |
| Applicant | KINETIC CONCEPTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EQN |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-04 |
| Decision Date | 1978-12-15 |