The following data is part of a premarket notification filed by The Dupont Merck Pharmaceutical Co. with the FDA for Viaspan (belzer Uw - Css).
| Device ID | K944866 |
| 510k Number | K944866 |
| Device Name: | VIASPAN (BELZER UW - CSS) |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | THE DUPONT MERCK PHARMACEUTICAL CO. EXPERIMENTAL STATION BLDG. 353 Wilmington, DE 19880 -0353 |
| Contact | James L Gaskill |
| Correspondent | James L Gaskill THE DUPONT MERCK PHARMACEUTICAL CO. EXPERIMENTAL STATION BLDG. 353 Wilmington, DE 19880 -0353 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1996-04-22 |
| Summary: | summary |