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

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

Haemonetics Corporation

The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.

Pre-market Notification Details

Device IDBK970029
510k NumberBK970029
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant Haemonetics Corporation 400 Wood Road Braintree,  MA  02184
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-05
Decision Date1998-01-07

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