The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Wound Treatment Kit.
| Device ID | K901109 |
| 510k Number | K901109 |
| Device Name: | WOUND TREATMENT KIT |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-09 |
| Decision Date | 1990-06-06 |