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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 K931106
Device Name BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
Applicant
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Applicant Contact MICHAEL SANTALUCIA
Correspondent
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Correspondent Contact MICHAEL SANTALUCIA
Regulation Number868.5830
Classification Product Code
CAC  
Subsequent Product Code
DTP  
Date Received03/03/1993
Decision Date 10/06/1993
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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