The following data is part of a premarket notification filed by Pausch Corp. with the FDA for Uromat 2000.
| Device ID | K903395 |
| 510k Number | K903395 |
| Device Name: | UROMAT 2000 |
| Classification | Table, Radiographic, Tilting |
| Applicant | PAUSCH CORP. 96 BIRCH AVE. Little Silver, NJ 07739 |
| Contact | Tice |
| Correspondent | Tice PAUSCH CORP. 96 BIRCH AVE. Little Silver, NJ 07739 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-27 |
| Decision Date | 1990-08-30 |