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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tank, Holding, Dialysis
510(k) Number K023011
Device Name OSMONICS SOLUTION DELIVERY SYSTEM
Applicant
Osmonics Medical Systems
7848 S. 202nd St.
Kent,  WA  98032
Applicant Contact KRISTINE KALISZEWSKI
Correspondent
Osmonics Medical Systems
7848 S. 202nd St.
Kent,  WA  98032
Correspondent Contact KRISTINE KALISZEWSKI
Regulation Number876.5820
Classification Product Code
FIN  
Date Received09/09/2002
Decision Date 06/26/2003
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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