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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 K992723
Device Name ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
Original Applicant
TRANSFUSION TECHNOLOGIES CORP.
9 erie dr.
natick,  MA  01760
Original Contact john j sokolowski
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/13/1999
Decision Date 10/18/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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