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Blood Establishment Computer Software And Accessories

Mediware Information Systems, Inc.

The following data is part of a premarket notification filed by Mediware Information Systems, Inc. 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 IDBK030078
510k NumberBK030078
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 Mediware Information Systems, Inc. 4545 Fuller Drive, Ste 320 Irving,  TX  75038 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Abbrevia
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-25
Decision Date2004-04-08

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