The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Urinary Care Supplies.
| Device ID | K923496 |
| 510k Number | K923496 |
| Device Name: | URINARY CARE SUPPLIES |
| Classification | Accessories, Catheter, G-u |
| 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 | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1993-05-27 |