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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K082923
Device Name PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
Original Applicant
4235 greenbriar dr.
stafford,  TX  77477 3995
Original Contact jeff kasoff
Regulation Number868.5830
Classification Product Code
Date Received10/01/2008
Decision Date 10/24/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No