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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK980023
Tradename SafeTrace TX, version 1.0
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Wyndgate Technologies
11060 white rock road
suite 200
rancho cordova,  CA  95670
Regulation Number864.9165
Classification Product Code
MMH  
Date Received07/24/1998
Decision Date 01/29/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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