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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 K113313
Device Name MOLECULAR ADSORBENT RECIRCULATING(MARS)
Applicant
Gambro Renal Products, Inc.
14143 Denver W. Pkwy.
Suite 400
Lakewood,  CO  80401
Applicant Contact KAE MILLER
Correspondent
Gambro Renal Products, Inc.
14143 Denver W. Pkwy.
Suite 400
Lakewood,  CO  80401
Correspondent Contact KAE MILLER
Regulation Number876.5870
Classification Product Code
FLD  
Date Received11/09/2011
Decision Date 12/14/2012
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
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