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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 BK960050
Tradename Progesa
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
MAK-System
z.i. paris nord ii
14, rue de la perdrix
95946 roissy c.d.g. cedex,  B.P. 50035, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received04/29/1996
Decision Date 12/10/1998
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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