The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
| Device ID | BK080033 |
| 510k Number | BK080033 |
| Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | Fenwal, Inc. three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2008-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04086000100342 | BK080033 | 0 |