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Blood Establishment Computer Software And Accessories

Duley Hopkins And Associates

The following data is part of a premarket notification filed by Duley Hopkins And Associates 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 IDBK090079
510k NumberBK090079
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 Duley Hopkins And Associates 1200 Mountain Creek Road # 215 Chattanooga,  TN  37405
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-17
Decision Date2010-01-13

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