Kit, Bone Marrow Collection

Bone Marrow Collection/transfusion Kit

Fenwal Inc

The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Kit, Bone Marrow Collection.

Pre-market Notification Details

Device IDBK090031
510k NumberBK090031
Device Name:Kit, Bone Marrow Collection
ClassificationBone Marrow Collection/transfusion Kit
Applicant Fenwal Inc three Corporate Drive 2nd Floor Lake Zurich,  IL  60047
Product CodeLWE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-23
Decision Date2009-07-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.