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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 K900483
Device Name VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
Applicant
BAXTER HEALTHCARE CORP.
1425 LAKE COOK RD.
DEERFIELD,  IL  60015
Applicant Contact CHARLES B MCNEIL
Correspondent
BAXTER HEALTHCARE CORP.
1425 LAKE COOK RD.
DEERFIELD,  IL  60015
Correspondent Contact CHARLES B MCNEIL
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/01/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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