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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 K881811
Device Name COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
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 Received04/28/1988
Decision Date 09/15/1988
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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