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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Hemoperfusion, Sorbent
510(k) Number K033262
Device Name MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
Applicant
Gambro Renal Products
10810 W Collins Ave.
Lakewood,  CO  80215
Applicant Contact KAE MILLER
Correspondent
Gambro Renal Products
10810 W Collins Ave.
Lakewood,  CO  80215
Correspondent Contact KAE MILLER
Regulation Number876.5870
Classification Product Code
FLD  
Date Received10/09/2003
Decision Date 05/27/2005
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 Yes
Predetermined Change
Control Plan Authorized		 No
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