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Blood Establishment Computer Software And Accessories

Haemonetics Corporation Software Solutions

The following data is part of a premarket notification filed by Haemonetics Corporation Software Solutions 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 IDBK150308
510k NumberBK150308
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 Software Solutions 4925 Robert J. Matthews Parkway suite 100 El Dorado Hills,  CA  95762
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-25
Decision Date2015-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812747010149 BK150308 0
00860007282713 BK150308 0

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