The following data is part of a premarket notification filed by Medical Inventors Corp., Inc. with the FDA for Bladder Cycler Closed-system Urinary Drain Bag.
| Device ID | K890096 |
| 510k Number | K890096 |
| Device Name: | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | MEDICAL INVENTORS CORP., INC. 7575 DR. PHILLIPS BLVD., SUITE #310 Orlando, FL 32819 |
| Contact | Roland C Zagnoli |
| Correspondent | Roland C Zagnoli MEDICAL INVENTORS CORP., INC. 7575 DR. PHILLIPS BLVD., SUITE #310 Orlando, FL 32819 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-10 |
| Decision Date | 1989-07-14 |