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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 K912019
Device Name ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
Original Applicant
GISH BIOMEDICAL, INC.
2350 s. pullman ave.
santa ana,  CA  92705
Original Contact debi kridner
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/07/1991
Decision Date 10/08/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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