The following data is part of a premarket notification filed by Medical Marketing Group with the FDA for O'neil Urinary Catheter Introducer.
| Device ID | K884819 |
| 510k Number | K884819 |
| Device Name: | O'NEIL URINARY CATHETER INTRODUCER |
| Classification | Accessories, Catheter, G-u |
| 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 | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-17 |
| Decision Date | 1989-02-17 |