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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Perfusion, Kidney, Disposable
510(k) Number K883782
Device Name BELZER UW-CSS
Applicant
Du Pont Critical Care
1600 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact JOHN H WATERMAN
Correspondent
Du Pont Critical Care
1600 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact JOHN H WATERMAN
Regulation Number876.5880
Classification Product Code
KDL  
Date Received09/06/1988
Decision Date 04/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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