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Blood Establishment Computer Software And Accessories

SCC Soft Computer

The following data is part of a premarket notification filed by Scc Soft Computer 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 IDBK090078
510k NumberBK090078
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 SCC Soft Computer 5400 Tech Data Drive Clearwater,  FL  33760
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-03
Decision Date2010-04-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859474006229 BK090078 0
00859474006151 BK090078 0
00859474006083 BK090078 0
00859474006045 BK090078 0
00859474006328 BK090078 0
00859474006526 BK090078 0
00810055812257 BK090078 0
00810055814145 BK090078 0
00810055815302 BK090078 0

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