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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K070414
Device Name GAMBRO CARTRIDGE BLOOD SETS
Applicant
Gambro Renal Products
10810 W Collins Ave.
Lakewood,  CO  80215
Applicant Contact THOMAS B DOWELL
Correspondent
Gambro Renal Products
10810 W Collins Ave.
Lakewood,  CO  80215
Correspondent Contact THOMAS B DOWELL
Regulation Number876.5820
Classification Product Code
FJK  
Date Received02/12/2007
Decision Date 10/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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