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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 BK950059
Tradename Safe Trace
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Wyndgate Technologies
11121 sun center drive
suite c
rancho cordova,  CA  95670
Regulation Number864.9165
Classification Product Code
MMH  
Date Received10/27/1995
Decision Date 04/14/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
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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