The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Foley Catheter Insertion Tray (30cc).
| Device ID | K901180 |
| 510k Number | K901180 |
| Device Name: | FOLEY CATHETER INSERTION TRAY (30CC) |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Contact | L Laemmar |
| Correspondent | L Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-07-20 |