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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 K941708
Device Name COBE CENTRYSYSTEM CS500 DIALYZER
Applicant
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received04/06/1994
Decision Date 05/12/1995
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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