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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 BK000026
Tradename P2K Plasma Center Module 2000
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
5D Information Management
suite 500, 10025 - 102a avenue
edmonton,  Alberta,  T5J 2Z2, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received05/25/2000
Decision Date 06/22/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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