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510(k) K890329

FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM by Fresenius USA, Inc. — Product Code FIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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