The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Continuous Blood Processor Cbp-6000 &.
| Device ID | K820243 |
| 510k Number | K820243 |
| Device Name: | CONTINUOUS BLOOD PROCESSOR CBP-6000 & |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-29 |
| Decision Date | 1982-03-25 |