The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Enema Bucket Set.
| Device ID | K901179 |
| 510k Number | K901179 |
| Device Name: | ENEMA BUCKET SET |
| Classification | Enema 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 | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-06-28 |