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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 K944866
Device Name VIASPAN (BELZER UW - CSS)
Applicant
The Dupont Merck Pharmaceutical Co.
Experimental Station Bldg. 353
Wilmington,  DE  19880
Applicant Contact JAMES L GASKILL
Correspondent
The Dupont Merck Pharmaceutical Co.
Experimental Station Bldg. 353
Wilmington,  DE  19880
Correspondent Contact JAMES L GASKILL
Regulation Number876.5880
Classification Product Code
KDL  
Date Received10/03/1994
Decision Date 04/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
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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