Processing Systems For Frozen Blood

System, Processing For Frozen Blood

Haemonetics Corporation

The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Processing Systems For Frozen Blood.

Pre-market Notification Details

Device IDBK030062
510k NumberBK030062
Device Name:Processing Systems For Frozen Blood
ClassificationSystem, Processing For Frozen Blood
Applicant Haemonetics Corporation 400 Wood Road Braintree,  MA  02184
Product CodeKSW  
CFR Regulation Number864.9145 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2003-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747015817 BK030062 0
30812747015800 BK030062 0
30812747015022 BK030062 0

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