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510(k) K023011

OSMONICS SOLUTION DELIVERY SYSTEM by Osmonics Medical Systems — Product Code FIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2003
Date Received
September 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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