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Blood Establishment Computer Software And Accessories

IT Synergistics, LLC

The following data is part of a premarket notification filed by It Synergistics, Llc 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 IDBK140091
510k NumberBK140091
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 IT Synergistics, LLC 115 Tree Street Flowood,  MS  39232
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-29
Decision Date2014-04-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00867268000407 BK140091 0

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