The following data is part of a premarket notification filed by Mri Manufacturing And Research, Inc. with the FDA for Mri's All Silicone Foley Catheter.
| Device ID | K944676 |
| 510k Number | K944676 |
| Device Name: | MRI'S ALL SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | MRI MANUFACTURING AND RESEARCH, INC. 2045 NORTH FORBES BLVD. SUITE 105 Tuscon, AZ 85745 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb MRI MANUFACTURING AND RESEARCH, INC. 2045 NORTH FORBES BLVD. SUITE 105 Tuscon, AZ 85745 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1996-04-05 |