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510(k) K002892

FRSENIUS PD IQCARD CYCLER by Fresenius Medical Care North America — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2001
Date Received
September 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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