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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 K070320
Device Name EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
Applicant
EDWARDS LIFESCIENCES SERVICES GMBH
BUSINESS & TECHNOLOGY CENTER
BESSEMER DRIVE
STEVENAGE, HERTSFORDSHIRE,  GB SG1 2DX
Applicant Contact NEIL R ARMSTRONG
Correspondent
EDWARDS LIFESCIENCES SERVICES GMBH
BUSINESS & TECHNOLOGY CENTER
BESSEMER DRIVE
STEVENAGE, HERTSFORDSHIRE,  GB SG1 2DX
Correspondent Contact NEIL R ARMSTRONG
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/02/2007
Decision Date 06/07/2007
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
Recalls CDRH Recalls
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