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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 K896858
Device Name SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
Applicant
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Applicant Contact BARBARA LAMBERT
Correspondent
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Correspondent Contact BARBARA LAMBERT
Regulation Number868.5830
Classification Product Code
CAC  
Date Received12/05/1989
Decision Date 04/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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