The following data is part of a premarket notification filed by Mri Manufacturing And Research, Inc. with the FDA for Mri's All Silicone Irrigation 3-way Foley Catheter.
| Device ID | K982970 |
| 510k Number | K982970 |
| Device Name: | MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | MRI MANUFACTURING AND RESEARCH, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Ed Ranson |
| Correspondent | Ed Ranson MRI MANUFACTURING AND RESEARCH, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-25 |
| Decision Date | 1998-10-28 |
| Summary: | summary |