The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Routine Dressing Tray.
| Device ID | K902811 |
| 510k Number | K902811 |
| Device Name: | ROUTINE DRESSING TRAY |
| Classification | Wound Dressing Kit |
| 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 | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-09-25 |