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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 K130039
Device Name REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
Applicant
GAMBRO RENAL PRODUCTS, INC.
14143 DENVER WEST PARKWAY
SUITE 400
LAKEWOOD,  CO  80401
Applicant Contact KAE MILLER
Correspondent
GAMBRO RENAL PRODUCTS, INC.
14143 DENVER WEST PARKWAY
SUITE 400
LAKEWOOD,  CO  80401
Correspondent Contact KAE MILLER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/07/2013
Decision Date 05/02/2013
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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