The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Tracheostomy Care Tray.
| Device ID | K923156 |
| 510k Number | K923156 |
| Device Name: | TRACHEOSTOMY CARE TRAY |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Contact | John Laemmar |
| Correspondent | John Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1993-08-18 |