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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K043126
Device Name ASSIST HEADER CLEANER
Applicant
ALCAVIS INTERNATIONAL, INC.
8-8 METROPOLITAN CT.
GAITHERSBURG,  MD  20878
Applicant Contact GARY J MISHKIN
Correspondent
ALCAVIS INTERNATIONAL, INC.
8-8 METROPOLITAN CT.
GAITHERSBURG,  MD  20878
Correspondent Contact GARY J MISHKIN
Regulation Number876.5820
Classification Product Code
LIF  
Date Received11/12/2004
Decision Date 02/03/2005
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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