The following data is part of a premarket notification filed by Du Pont Critical Care with the FDA for Belzer Uw-css.
| Device ID | K883782 |
| 510k Number | K883782 |
| Device Name: | BELZER UW-CSS |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | DU PONT CRITICAL CARE 1600 WAUKEGAN RD. Waukegan, IL 60085 |
| Contact | John H Waterman |
| Correspondent | John H Waterman DU PONT CRITICAL CARE 1600 WAUKEGAN RD. Waukegan, IL 60085 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1989-04-20 |