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

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

Haemonetics Manufacturing Inc.

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

Pre-market Notification Details

Device IDBK060045
510k NumberBK060045
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant Haemonetics Manufacturing Inc. 400 Wood Road Braintree,  MA  02184
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-01
Decision Date2006-09-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30887691308193 BK060045 0

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