Empty Containers For The Collection & Processing Of Blood/Blood Components

Container, Empty, For Collection & Processing Of Blood & Blood Components

Fenwal Inc

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.

Pre-market Notification Details

Device IDBK110066
510k NumberBK110066
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant Fenwal Inc three Corporate Drive Lake Zurich,  IL  60047
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-18
Decision Date2012-02-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14086000101421 BK110066 0

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