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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Perfusion, Kidney, Disposable
510(k) Number K955497
Device Name GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
Applicant
Cobe Renal Care, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55424
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Cobe Renal Care, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55424
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5880
Classification Product Code
KDL  
Date Received12/01/1995
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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