The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Kit, Bone Marrow Collection.
Device ID | BK090031 |
510k Number | BK090031 |
Device Name: | Kit, Bone Marrow Collection |
Classification | Bone Marrow Collection/transfusion Kit |
Applicant | Fenwal Inc three Corporate Drive 2nd Floor Lake Zurich, IL 60047 |
Product Code | LWE |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-23 |
Decision Date | 2009-07-23 |