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Blood Establishment Computer Software And Accessories

Haemonetics Corporation

The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK090041
510k NumberBK090041
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationBlood Establishment Computer Software And Accessories
Applicant Haemonetics Corporation 400 Wood Road Braintree,  MA  02184
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-10
Decision Date2009-09-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812747010194 BK090041 0

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