The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Trachael Suction Set.
| Device ID | K896887 |
| 510k Number | K896887 |
| Device Name: | TRACHAEL SUCTION SET |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Contact | John L Laemmar |
| Correspondent | John L Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-08 |
| Decision Date | 1990-04-23 |