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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K904566
Device Name NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
Applicant
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact MARY L ARMSTRONG
Correspondent
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact MARY L ARMSTRONG
Regulation Number876.5820
Classification Product Code
FJI  
Date Received10/09/1990
Decision Date 12/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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