The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Transfer Sets.
| Device ID | BK910014 |
| 510k Number | BK910014 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Fenwal Inc three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-01 |
| Decision Date | 1991-09-18 |