The following data is part of a premarket notification filed by Bellco Artifidial Organ Spec., Inc. with the FDA for The Vita 2 Disposable Dialyzer.
| Device ID | K801634 |
| 510k Number | K801634 |
| Device Name: | THE VITA 2 DISPOSABLE DIALYZER |
| Classification | Dialyzer, Single Coil |
| Applicant | BELLCO ARTIFIDIAL ORGAN SPEC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FHS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-15 |
| Decision Date | 1980-12-17 |