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Blood Establishment Computer Software And Accessories

Soft Computer Consultants Inc.

The following data is part of a premarket notification filed by Soft Computer Consultants 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 IDBK040048
510k NumberBK040048
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 Soft Computer Consultants Inc. 34350 U.s. Hwy 19 N. Palm Harbor,  FL  34684 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Abbrevia
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-19
Decision Date2004-08-23

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