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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 K133807
Device Name MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
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  
Subsequent Product Code
KDI  
Date Received12/16/2013
Decision Date 03/26/2014
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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