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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Parallel Flow
510(k) Number K933680
Device Name GAMBRO LUNDIA PRO 200 DIALYZER
Applicant
Cobe Renal Care, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Cobe Renal Care, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
FJG  
Date Received07/29/1993
Decision Date 08/26/1994
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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