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 IDBK840010
510k NumberBK840010
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) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-16
Decision Date1984-08-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30887691312381 BK840010 0
30887691002879 BK840010 0
30887691002855 BK840010 0
30887691002848 BK840010 0
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