The following data is part of a premarket notification filed by Medical Marketing Group with the FDA for Mmg/o'neil Urinary Catheterization System Kit.
| Device ID | K910022 |
| 510k Number | K910022 |
| Device Name: | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
| Contact | Timothy D Golden |
| Correspondent | Timothy D Golden MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
| 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 | 1991-01-03 |
| Decision Date | 1991-04-02 |