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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 K864831
Device Name COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
Applicant
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number876.5820
Classification Product Code
FJI  
Date Received12/09/1986
Decision Date 03/27/1987
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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