The following data is part of a premarket notification filed by Key Medical Services, Inc. with the FDA for Urinary Drainage Bag.
| Device ID | K951597 |
| 510k Number | K951597 |
| Device Name: | URINARY DRAINAGE BAG |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Applicant | KEY MEDICAL SERVICES, INC. 5901 N. MILWAUKEE AVE. Chicago, IL 60646 |
| Contact | Robert E Gore |
| Correspondent | Robert E Gore KEY MEDICAL SERVICES, INC. 5901 N. MILWAUKEE AVE. Chicago, IL 60646 |
| Product Code | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-08-04 |