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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
Applicant
Transfusion Technologies Corp.
9 Erie Dr.
Natick,  MA  01760
Applicant Contact JOHN J SOKOLOWSKI
Correspondent
Transfusion Technologies Corp.
9 Erie Dr.
Natick,  MA  01760
Correspondent 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 Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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