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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K131516
Device Name PRISMAFLEX SYSTEM 7.10
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 Number876.5860
Classification Product Code
KDI  
Date Received05/28/2013
Decision Date 01/03/2014
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 No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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